CURE Talks Cancer

The FDA is certainly staying busy as 2023 comes to a close, approving three treatments for patients with cancer last week alone.

Additionally, exciting study findings were released regarding a cancer vaccine for the treatment of melanoma.

FDA Approves Iwilfin for High-Risk Neuroblastoma in Adults and Children

The FDA approved has Iwilfin (eflornithine) for the treatment of adult and pediatric patients with high-risk neuroblastoma who have shown at least a partial response to a previous multiagent modality therapy, which includes anti-GD2 immunotherapy.

Notably, the FDA reported that this drug is the first approval of a therapy used to reduce the risk of relapse in children with high-risk neuroblastoma. Neuroblastoma, as the National Cancer Institute explained on its website, is a cancer of immature nerve cells that most typically occurs in children, and often begins in the adrenal glands.

The FDA said the major efficacy outcome measure behind the approval was event-free survival (EFS; time after treatment when cancer does not come back or worsen; disease progression), while other notable findings included overall survival (OS; length of time from diagnosis or start of treatment when a patient is still alive).

FDA Approves Welireg for Advanced Kidney Cancer Subtype

The FDA approved Welireg ((beluztifan) for patients with advanced renal cell carcinoma (RCC) who have been previously treated with a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).

The approval was based on findings from the LITESPARK-005 trial. Trial findings presented earlier this year at the European Society of Medical Oncology Annual Congress (ESMO) showed that at a median follow-up of 18.4 months, patients treated with Welireg experienced objective response rates (patients whose disease responded partially or completely to treatment) of 21.9%, compared with 3.5% among patients treated with Afinitor (everolimus), and 12-month progression-free survival (PFS; the time a patient lives without their disease spreading or

worsening) rates were 33.7% on Welireg versus 17.6% with Afinitor, and 18-month PFS rates were 22.5% and 9%, respectively.

FDA Approves Padcev-Keytruda Combo in Advanced Bladder Cancer

The FDA has additionally approved Padcev (enfortumab vedotin-ejfv) plus Ketruda (pembrolizumab) for patients with locally advanced or metastatic bladder cancer. Alongside this, the FDA previously granted an accelerated approval for this patient population who are unable to be treated with cisplatin-containing chemotherapy.

In the recent EV-302/KN-A39 trial, both OS and PFS showed significant improvements among the Padcev plus Keytruda group of patients, as the median overall survival for these patients was 31.5 months, while a cohort treated with chemotherapy experienced a median OS of 16.1 months.

Regarding progression-free survival, the median was 12.5 months for the Padcev-Keytruda combination group and 6.3 months in the chemotherapy group.

Cancer Vaccine Plus Keytruda Reduces Risk of Recurrence or Death in Melanoma

Patients with advanced-stage melanoma continue to experience reduced risk of recurrence or death following treatment with a combination of mRNA vaccine mRNA-4157 (V940), an investigational individualized neoantigen therapy (INT), and Keytruda, according to recent study findings.

The mRNA-4157 (V940) and Keytruda combination reduced the risk of recurrence or death by 49% and the risk of distant metastasis or death by 52% when compared with treatment with Keytruda alone in patients with stage 3 or 4 melanoma with high risk of recurrence following complete resection, as determined by the phase 2b KEYNOTE-942/mRNA-4157-P201 study, according to a news release from drug manufacturers Moderna and Merck.

The latest findings, from a median planned follow-up of approximately three years, build on previously announced primarily analysis data from a median planned follow-up of approximately two years which showed that the combination reduced the risk of recurrence or death by 44% and the risk of distance metastasis or death by 65% when compared with Keytruda alone.

Based on the trial’s findings, the Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to the combination for the post-surgical treatment of patients with high-risk melanoma earlier this year.

Moderna and Merck have also announced the phase 3 INTerpath-001 (V940-001) clinical trial to evaluate the combination as an adjuvant treatment for patients with resected, high-risk stage 3B to 4 melanoma, which is currently enrolling participants, as well as a phase 3 trial for the treatment of patients with non-small cell lung cancer treated with the combination regimen.

For more news on cancer updates, research and education, don’t forget to subscribe to CURE®’s newsletters here.

This past weekend, the CURE® staff was busy covering the American Society of Hematology (ASH) Annual Meeting.

ASH is the largest blood cancer conference in the country, and thousands of abstracts were presented. Now, we’re bringing you some of the highlights from the conference.

And, to view all of our conference coverage, be sure to check out curetoday.com/conference

Navitoclax Plus Jakafi Improves Spleen Volume Reductions in Myelofibrosis

Spleen enlargement is a common and often problematic symptom of myelifbrosis. However, recent findings from the phase 3 TRANSFORM-1 trial found that combining the novel drug, navitoclax with Jakafi was successful in reducing spleen volume in this patient population.

The main outcome that the researchers were looking at in this study was the percentage of patients who had a spleen volume reduction of 35% or more at certain time points. Findings showed that by week 24, 64.2% of patients who had the navitoclax regimen experienced this level of spleen reduction, compared to only 31.5% of patients who received placebo plus Jakafi — that’s a significant overall difference of 31%.

Navitoclax is not currently approved in any indication, but AbbVie, the pharmaceutical company behind the agent, plans to submit the drug for FDA approval in 2023, pending study results.

Brukinsa Lengthens Time to Progression in Relapsed/Refractory CLL, SLL

There are currently three BTK inhibitors for the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL and SLL, respectively), though a lack of research exists that compares these drugs head-to-head.

Now, the phase 3 ALPINE trial was the first study to directly compare two BTK inhibitors, Brukinsa and Imbruvica, in patients with relapsed or refractory CLL or SLL. Findings showed that after about 39 months of follow-up, patients given Brukinsa tended to live longer before death or disease progression — a statistic experts refer to as “progression-free survival.” In the general patient population, Brukinsa reduced the risk of disease progression by 32%, and for patients with 17p deletion and/or TP53 mutations — subtypes that typically indicate aggressive disease — there was a 48% reduction in the risk of disease progression.

Abecma May Improve Quality of Life in Previously Treated Myeloma

The phase 3 KarMMA-3 trial showed that Abecma significantly improved symptoms, functioning and health-related quality of life in patients with relapsed or refractory multiple myeloma who previously underwent two to four prior treatments.

Abecma is a CAR-T cell therapy, which is a newer type of treatment for blood cancers. It involves taking patients’ blood out, and re-engineering their T cells to find and fight cancer. After they’re multiplied, those new T cells are infused back into the patient.

Findings from the KarMMA-3 trial showed that Abecma led to improvements in fatigue and pain compared with other standard regimens in this patient population.

The last week was a busy one for us here at CURE® and across the oncology space in general. There were two major meetings we covered: the San Antonio Breast Cancer Symposium and the American Society of Hematology Annual Meeting. 


The San Antonio Breast Cancer Symposium — also known as SABCS — features breast cancer research conducted around the globe. We had editors on the ground in San Antonio, as well as back in our office covering the meeting. Here are some highlights from SABCS. 


And, to view all of our conference coverage, be sure to check out curetoday.com/conference

Kadcyla Is the ‘First Therapy to Show Improved Survival’ in a Breast Cancer Subset


For in patients with HER2-positive early breast cancer that still had remaining invasive disease after undergoing neoadjuvant therapy Kadcyla outperformed Herceptin when it came to overall survival, which is the time until death of any cause, and invasive disease-free survival, which is the time patients live without experience metastases or invasive disease. 


The findings, which come out of the KATHERINE trial, mark the “first therapy to show an improved survival after post-surgical therapy in patients with HER2-positive early breast cancer and residual invasive disease after neoadjuvant therapy,” according to study author, Dr. Sibylle Loibl, who presented the findings at SABCS. 


More specifically, at the 8.4-year follow-up mark, 70.1% of patients in the Kadcyla group and 62% in the Herceptin group were still alive. Also at that point, 32.2% given Kadcyla did not develop invasive disease, compared with 19.7% of patients in the Herceptin group. 

Keytruda, Chemo Show Early-Stage Breast Cancer Event-Free Survival Benefits


Findings from phase 3 KEYNOTE-522 trial showed that presurgical Keytruda plus chemotherapy, followed by postsurgical Keytruda led to improved event-free survival — that’s time a patient lives without complications from their disease — in patients with high-risk, early-stage triple-negative breast cancer. 


At a median follow-up of 63.1 months, the five-year event-free survival rate was 81.3% with neoadjuvant Keytruda/chemotherapy followed by adjuvant Keytruda compared with 72.3% in those who received placebo/chemotherapy and then placebo. These findings, according to Dr. Peter Schmid, further support the use of this Keytruda regimen as the standard of care for this patient population. 

Tecentriq Plus Perjeta, Herceptin, Chemo Does Not Improve pCR in HER2+ Breast Cancer


Another phase 3 trial — the APTneo Michelangelo — showed that adding Tecentriq and Herceptin to Perjeta and chemotherapy actually did not lead to a statistically significant improvement in pathologic complete response (that’s the disappearance of cancer) when given in the presurgical setting for patients with HER2-positive breast cancer. 


The study found that while Tecentriq and Herceptin-containing regimens did lead to a higher number of pathologic complete responses, these difference between the two treatment groups was not statistically significant, meaning that the researchers could not definitively say that one therapy was the result of better outcomes. 

No Racial Difference in Recurrence-Free Survival in HR+, HER2- Breast Cancer


While research has shown that Black and White patients with HR-positive, HER2-negative breast cancer tend to have different survival outcomes, research presented at SABCS found that three-year recurrence-free survival is actually comparable between the two groups. 

 “More aggressive treatment can improve outcomes for (patients with HR-positive, basal-type tumors), as demonstrated by improved (overall survival) in (those who) achieved pathologic complete response,” study investigators stated in the poster. “These data highlight the importance of genomic testing to help optimize treatment and reduce outcome disparities in Black women.”

Blood cancer treatments — and one treatment type, in particular — were the point of much discussion last week. The FDA said that it is investigating instances of secondary malignancies in patients with blood cancers treated with CAR-T cell therapy. Also, the drug manufacturer for a novel CAR-T cell therapy submitted an application to introduce the treatment into the United States market. 
Blood cancers will continue to be a hot topic this week, as later in the week we’ll be covering the American Society of Hematology Annual Meeting. And before that, we’ll also be covering the San Antonio Breast Cancer Symposium. 


Chance or CAR-T: Expert Weighs in on FDA Investigation


One of the biggest headlines in the cancer space last week was that the Food and Drug Administration (FDA) announced that they are investigating instances of T-cell malignancies — such as CAR-positive lymphoma — occurring in patients with blood cancers that were treated with CAR-T cell therapy. 

CAR-T cell therapy is a newer type of blood cancer treatment that involves extracting patients’ blood and reengineering their immune T cells to find and fight cancer. Those new T cells are then multiplied and infused back into the patient. Since the first CAR-T cell product was approved in 2017, this treatment modality has drastically improved outcomes for patients with certain types of blood cancers. 

It’s worth mentioning that the FDA’s Nov. 28 report about T-cell malignancies did not definitively say that CAR-T cell therapies are directly causing secondary diseases. They also did not mention the frequency at which these T-cell malignancies are occurring. I spoke with Dr. John Lister, who said that perhaps it’s the manufacturing process that could be the root cause, but perhaps it is also just chance, as research has shown that many patients with cancer hold a higher risk of developing a second cancer. For now, we’re just going to have to wait and see what further data tells us. 

FDA Biologics License Application Filed for Obe-Cel for Adult R/R B-ALL

Also in CAR-T cell therapy news, last week a pharmaceutical company submitted a Biologics License Application to the FDA for their CAR-T cell therapy, obe-cel to be used for patients with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). 


When a pharmaceutical company files a Biologics License Application to the FDA, they’re essentially asking the agency to allow them to bring the drug to the market. The company submitting the drug must provide the FDA with multiple pieces of information, including findings from preclinical and clinical studies showing that the drug is safe. 

In this instance, the pharmaceutical company cited data from the FELIX study, from which, early data showed that 76% if patients responded to the therapy, including 54.3% who had a complete response, meaning that their disease essentially disappeared. Now, updated findings from the trial will be presented at the upcoming ASH Annual Meeting happening next week.  

For patients with cervical cancer who are negative for high-risk human papillomavirus (HPV) with normal or low-grade cytology, a prolonged follow-up interval of six months could be offered six to 24 months after receiving fertility-sparing surgery, according to the findings of a recent study.


Researchers, writing in a study published in The Lancet Oncology, noted that patients who are negative for high-risk HPV and have normal or low-grade cytology — a type of screening that collects cervical cells to be checked for changes caused by HPV that may turn into cancer, as explained by the National Cancer Institute — make up 80% of patients who receive fertility-sparing surgery, and that a 12-month interview “seems to be safe” following two consecutive negative high-risk HPV tests and an absence of high-grade cytology, which applies to 75% of all patients who receive fertility-sparing surgery. 


Current guidelines in both the United States and Europe, researchers explained, recommend a six- to 12-month interval between follow-up visits for two years after fertility-sparing surgery, with a total follow-up of five years.

Learn more: HPV Causes Multiple Cancers, Though Knowledge on the Connection Is Lagging


“The development of a tailored surveillance strategy after fertility-sparing surgery could contribute to improved efficiency of follow-up in patients with cervical cancer and subsequently reduce costs in health care,” wrote the researchers behind the population-based retrospective cohort study, which utilized data from the Netherlands Cancer Registry and the Dutch Nationwide Pathology Data Bank on more than 1,400 patients ages 18 to 40 with cervical cancer who received fertility-sparing surgery between Jan 1, 2000 and Dec 31, 2020.


Kate Weissman, a cervical cancer survivor, welcomes such research advancements.


“(It's) well overdue and certainly something that the cervical cancer community is owed, given that it's something that has not been paid attention to for so long,” she said. “It's always been really just (about) luck of the of the draw in who your oncologist is and who your team of doctors are to even discuss your fertility. So, I think that this is really long overdue, and I'm glad that the attention is on it, finally, for women.”


When Weismann received a diagnosis of stage 2B cervical cancer in 2015 at the age of 30, two years after being diagnosed with HPV, she was also told by her oncologist that she would not be able to carry children.


Kate began IVF, froze nine embryos and received treatment via 55 rounds of radiation, 17 rounds of chemotherapy and surgery before being declared cancer-free in 2016. She and her husband, Matt, eventually had a daughter, Louella, via surrogacy.


Now an ambassador for Cervivor, a community of patient advocates working with those affected by cervical cancer, and a 2023 Cervivor Champion Recipient, Weissman is also the Massachusetts State Lead Ambassador for the American Cancer Society Cancer Action Network.

Learn More: Why Patients Need to Remain Vigilant, Even When Dealing With Scanxiety


“When I ended my treatment in 2016, I was initially going for scans every three to six months. And then, after a couple of years, I was slowly able to extend those scans out, so now I go annually,” she said. “I will tell you, the anxiety is always with you. It never loosens its grip; you are always worried about (the cancer) coming back. And even though I'm lucky to only have to deal with scanxiety — as we call it in the cervical cancer community and really the cancer community in general once a year — it's really intense and I still have to keep up-to-date on my antianxiety medications and my therapy sessions and everything. 


“Now that I have a child it's really made that anxiety of the cancer coming back all that more intense, and it feels like a lot more is at stake. But I am lucky that I survived, and it's a once-a-year thing for me. … I have access to a medical team that is going to always watch me and look out for me, and I'm aware of my own body and everything I need to be on the lookout for too in the years post-treatment. So, that's been certainly something that it never loosens its grip on you. Even when you find out (that) you're cancer-free, you're in this for the rest of your life.”

For more news on cancer updates, research and education, don’t forget to subscribe to CURE®’s newsletters here.

The end of the year typically brings a number of FDA approvals, and 2023 is no different. Last week, the Food and Drug Administration approved a new drug, Augyro (repotrectinib) for the treatment of patients with ROS1-positive non-small cell lung cancer. 


Also making oncology headlines this week, is an expert update on the cancer drug shortage, research about how the severity of diabetes can impact colorectal cancer outcomes and how vitamin D may be able to mitigate the severity of chemotherapy-induced peripheral neuropathy.
 


FDA Approves Augtyro for Patients With NSCLC Subset


Another week, another FDA approval. This time, the agency approved Augtyro for the treatment of patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer. 


The drug works by targeting ROS1 oncogene fusions, which can be responsible for the growth of cancer. The approval was based off findings from the phase 1/2 TRIDENT-1 clinical trial, which showed that 79% of patients responded to therapy with the drug, including 6% who experienced a complete response, which is when all signs of cancer disappear. 


Bristol Myers Squibb, the pharmaceutical company that manufacturers Augtyro, expects the drug to be available to patients in mid-December. 

FDA Approves Keytruda plus Chemo for Advanced HER2-Negative Gastric, GEJ Cancers


Also in FDA news last week, the agency approved the immunotherapy drug, Keytruda, in combination with chemotherapy for the treatment of patients with advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma. 


The approval came after findings from the KEYNOTE-859 trial showed that the immunotherapy-chemo combination improved overall survival) that’s time from treatment until death of any cause); progression-free survival (time from treatment until death or disease worsening) and response rate compared to a group that received placebo plus chemotherapy. 

FDA Approves Truqap Plus Chemo for Some With HR-Positive, HER-Negative Breast Cancer


Additionally, the FDA has approved Truqap with chemotherapy fulvestrant for the treatment of adults with HR-positive or HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations and who have progressed on at least one endocrine-based regimen in the metastatic setting or recurred at or within one year of completing adjuvant therapy. And now this approval was based on the results of the CAPItello-291 trial

where among patients with these altered tumors, the median progression free survival was 7.3 months in the Truqap and chemotherapy cohort and 3.1 months in the placebo and chemotherapy cohort.

FDA Approves Xtandi for High-Risk Prostate Cancer


And the FDA approved Xtandi for the treatment of patients with non-metastatic castration-sensitive prostate cancer, with a high risk of biochemical recurrence, meaning a recurrence that is determined by rising prostate specific antigen levels. According to Pfizer, the manufacturer of the drug, and notably, this marks the first approval of an androgen receptor signaling inhibitor that is FDA approved for this patient population. 


The approval is based on findings from the randomized phase 3 EMBARK clinical trial were five-year metastasis free survival, which is the time from treatment until metastatic disease was 87.3% in the Xtandi arm, compared with 71.4% and the leuprolide-only group and 80% in the monotherapy group, according to findings that were published in the New England Journal of Medicine. 

Drug Shortages Continue to Be a ‘Serious Problem’ in Oncology


While the shortage of the chemotherapy drugs, cisplatin and carboplatin, seems to be improving, drug shortages, in general, are not a new problem and likely are not going anywhere soon, according to Corey McEwen, the director of oncology pharmacy services at Massachusetts General Hospital in Bostin.  


McEwen explained that most of these drugs are manufactured outside of the United States. The FDA will approve certain locations to make the drugs, which then are shipped to the wholesaler, then the cancer treatment center or clinic and finally, to the patients. However, at no point during that process is there an obligation to be transparent about drugs that are in shortage or at risk to be in shortage. 


Additionally, with increased demand and decreased supply, the price of these therapies can go up. At Mass. General, McEwen said that the institution will oftentimes take on the financial burden of the increased cost, because they are mainly focused on getting the drugs in the first place. However, that may not be the case in all cancer treatment centers, leading to more disparities and financial burdens from cancer care. 

Diabetes Severity Associated With Poor Colorectal Cancer Survival


Research published in the journal, Cancer, analyzed outcomes for patients with diabetes and colorectal cancer who underwent surgery for their cancer. Findings showed that patients with more severe diabetes tended to have poorer survival outcomes. This was particularly the case for patients who were female or in their earlier stages of cancer. 


The researchers theorized that the relationship between diabetic severity and cancer prognosis may be explained by three mechanisms: 

·      Diabetes can lead to increased levels of insulin-like growth, which can accelerate tumor growth 

·      High blood sugar levels may result in poor response to chemotherapy 

·      The potential increased accumulation of genetic mutations that result from the high inflammatory burden caused by diabetes 

Vitamin D May Help Prevent Chemo-Induced Neuropathy


Once again, vitamin D made oncology headlines last week. This time, findings published in the Journal of the National Comprehensive Cancer Network found that patients who were deficient in vitamin D before starting treatment with paclitaxel had higher rates of chemotherapy-induced peripheral neuropathy than patients with sufficient vitamin D levels. 


Peripheral neuropathy is a common side effect from certain types of chemotherapy drugs that presents as numbness, tingling or a stabbing feeling in the hands and/or feet. Eventually if the neuropathy gets so bad, patients can have a higher risk of falls or become unable to perform some essential everyday tasks, such as preparing food or getting dressed. There is currently no cure for the condition, so potential prevention or mitigation strategies — like getting enough vitamin D — are particularly important. 


I spoke with study author Dr. Dan Hertz who said that while more research is needed in this space, it is worth it for patients to check their vitamin D levels and take a supplement, if needed. 

It’s been a decade since Thom Filicia, acclaimed interior designer and former co-star of “Queer Eye for the Straight Guy,” served as a bone marrow donor for his brother, Jules, who had received a diagnosis of myelofibrosis.

“It was a disease I knew nothing about, I’d never even heard of it before,” Filicia told CURE®. “So that, in and of itself, was a very unusual situation, to have to navigate that. … In (Jules’) situation, we needed to move very quickly. And, in his case, the most appropriate (treatment) at that time, was a bone marrow transplant, so that's what we needed to do.”

Myelofibrosis, as explained by the MPN Research Foundation, is a type of chronic blood cancer that involves the formation of excessive scar tissue in the bone marrow, impairing the patient’s ability to produce normal blood cells. It is part of a category of blood cancers known as myeloproliferative neoplasms, or MPNs.

“Myelofibrosis is a challenge, because first of all, it’s (a) very rare disease, we’re talking about 25,000 people in the United States have this, maybe one in 500,000 people worldwide have this disease, so it’s a very rare disease,” explained Dr. Andrew Kuykendall of the department of malignant hematology at the Moffitt Cancer Center in Tampa. 

The presentation of myelofibrosis can also vary from patient to patient, as Kuykendall explained.

“People can either present with just abnormal blood counts, they can present with painful abdominal pain or splenomegaly, where their spleen is enlarged or other organs can be enlarged, (or) it could be from having fevers, chills, night sweats, bone pain, a lot of symptoms that bring them to that healthcare,” Kuykendall said. “And so, it's one of those things where all those people could come with a variety of symptoms yet receive the same diagnosis. And I think that that's challenging because it doesn't necessarily present in one way. There's no kind of map. We often say, ‘The disease doesn't read the textbook,’ and that's very true when it comes to myelofibrosis.”

A decade after the bone marrow transplant, Filicia says his brother is in great health, and he looked back on the transplant process as a “pretty seamless” experience.

“It was a good experience for both of us and a positive outcome, which is really great,” Filicia said. “I would say what it does in terms of (our relationship), we're blood brothers at a level that is very different than just being brothers because we now share the same DNA. And we've gone through this experience together, and it was a pretty impactful experience.”

Filicia has now partnered with biopharma company GSK to launch the online initiative Mapping Myelofibrosis, dedicated to raising awareness about the disease with input from organizations including the MPN Research Foundation and MPN Advocacy and Education International. 

The initiative’s website, mappingmf.com, includes educational and informational materials as well as podcast episodes and stories from members of the myelofibrosis community of patients and loved ones, Filicia among them.

“To be a resource or to be impactful in that situation, you really need information, and you need to know that you're not the only person going through it, you need to understand what other people are going through, you need to be able to connect with a doctor like Dr. Kuykendall where they can explain things to you in a way that you understand it,” Filicia said. 

“And that gives you hope, and that gives you the ability to, I would imagine, move forward in a positive, thoughtful, empowered way where you feel like you're making the best decisions that you can make, for your situation, with the best guidance that you feel comfortable with.”

Filicia and Kuykendall spoke with CURE®’s “Cancer Horizons” podcast about myelofibrosis, persistent misconceptions regarding bone marrow donation and the motivation behind the Mapping Myelofibrosis.

For more news on cancer updates, research and education, don’t forget to subscribe to CURE®’s newsletters here.

Last week was Veterans’ Day, and for some individuals in the armed service, that means reflecting back on their service, as well as the potential cause of their cancer. For both print and web-first features, CURE® spoke with veterans about their cancer journeys, including one Iraq veteran whose cancer was likely caused by exposure during his deployment overseas. 

Regarding new drug indications last week, the FDA seemed to be working in the gastrointestinal space: we saw a new drug approved for certain patients with colorectal cancer, and other indication in the gastric cancer space slightly changed from the way it was originally approved a few years ago. 

Finally, it is the open enrollment period for people who are eligible for Medicare. We heard from an expert at City of Hope about why patients with cancer should do their research before choosing a plan. 

Veteran, Colon Cancer Survivor Explains Importance of PACT Act 

Last year, President Joe Biden signed the bipartisan Sergeant First Class Heath Robinson Honoring our Promise to Address Comprehensive Toxics (PACT) Act into law last year, with the White House calling it “the most significant expansion of benefits and services for toxic exposed veterans in more than 30 years.”

More than 4.1 million veterans received free toxic exposure screenings through the VA, with the government processing nearly half a million PACT Act claims and delivering more than $1.85 billion in PACT Act-related benefits to veterans and survivors, including $215 million in benefits to veterans with cancer, during the first year of the PACT Act, the White House stated.

Under the PACT Act, for example, all gastrointestinal cancers are considered toxic exposure presumptive conditions — meaning veterans do not have to prove that the cancer started during or worsened because of their military service — for veterans from the Gulf War and post-9/11 eras such as Dan Nevins, a U.S. Army Reserve veteran and stage 3 colon cancer survivor who served in Iraq.

Read more: Veterans On The Front Lines of Lung Cancer

Dan is a bilateral, below-knee amputee living with a traumatic brain injury as a result of his service, and he received his cancer diagnosis in late 2021.

Spoke with us about his experiences being exposed to burn pits in Iraq.

FDA Approves Fruzaqla for Previously Treated Metastatic Colorectal Cancer


Last week came with another Food and Drug Administration approval in the oncology space. Fruzaqla for patients with metastatic colorectal cancer that has been previously treated with certain chemotherapy drugs, anti-VEGF therapies, and — if the patient has RAS wildtype disease and its medically appropriate — an anti-EGFR therapy. 

The approval, which was announced on Wednesday night, was based on findings from two clinical trials: FRESCO and FRESCO-2, which both showed that Fruzaqla improved overall survival (time from treatment until death of any cause) compared to placebo in this patient population. 

Of note, Fruzaqla is an oral drug that is not a chemotherapy agent, which may help patients avoid an abundance of clinics for treatment, as well as some of the side effects associated with chemotherapy, though we should note that Fruzaqla, like all drugs, does have its own set of potential side effects. 

FDA Amends Keytruda Approval for Gastric, GEJ Cancer


Also on the FDA front, the agency announced on Thursday that it was revising the approval indication of Keytruda plus Enhertu and chemotherapy for the frontline treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma. 

The Keytruda-containing regimen was originally approved in May 2021 and was for patients regardless of their cancer’s PD-L1 status. PD-L1 is a protein found on the surface of tumor cells and acts as a kind of cloak of invisibility from the immune system. Checkpoint inhibitor drugs like Keytruda inhibit the function of PD-L1, thereby allowing the immune system to find and fight the cancer.

With the amended approval, the FDA is now stating that this Keytruda regimen should only be used in patients whose cancers have that PD-L1 protein, as determined by a companion diagnostic test. 

This change came after follow-up data from the KEYNOTE-811 trial were presented at the European Society for Medical Oncology Congress a couple of weeks ago. The findings showed that while the Keytruda plus Enhertu and chemotherapy improved outcomes over placebo plus Enhertu and chemotherapy, the benefit was particularly better for those whose disease was PD-L1 positive. 

When It Comes to Cancer Care, Not All Medicare Plans Are the Same

The Medicare open enrollment period has officially begun and will run until Dec. 7. 

In a CURE® exclusive article penned by Dr. Harlan Levine of the City of Hope, a popular type of Medicare — Medicare Advantage — is outlined, along with their potential pros and cons when facing a cancer diagnosis. For example, did you know what while Medicare Advantage tends to be a more affordable option, it may not cover research medical centers that provide patients with cancer access to advanced treatments and clinical trials? 

Dr. Levine and others are advocating for Medicare Advantage to cover treatment at comprehensive cancer centers, but until then, he warns individuals to be weary of the plans that they choose and always read the fine print. 

 For more news on cancer updates, research and education, don’t forget to subscribe to CURE®’s newsletters here.

Last week brought the approval of two new cancer therapies, as well as some data about the ongoing cancer drug shortage and which groups of patients may be affected most. Also, CURE® spoke to an expert about how sexual activity — while not a requirement — may help follow-up exams be more comfortable for cervical cancer survivors. 

In this episode we’re looking back at the top oncology news from last week, and brining patients the information they need to know. 

Patients on Medicaid Disproportionately Affected by Drug Shortage


Despite initiatives from the federal government, the shortage of chemotherapy drugs — namely cisplatin and carboplatin — continues. Now, a recent survey from the American Cancer Society Cancer Action Network found that patients who are insured by Medicaid are three times more likely to be affected by the chemo shortage than individuals who get their health insurance through their provider. Findings also showed that 38% of patients who experienced delays in treatment had delays that lasted a month or more, while 35% said that they had difficulty getting insurance to fill a prescription related to a shortage, such as a substitute drug. 

Back in September, the White House outlined steps that they’re taking to mitigate the ongoing drug shortage, such as collaborating with health care providers and drug manufacturers. 

FDA Approves Loqtorzi Regimens for Advanced Nasopharyngeal Carcinoma 


The first of two FDA approvals last week happened on Monday, Oct. 30, when the agency approved Loqtorzi plus the chemotherapy drugs, gemcitabine and cisplatin, for the treatment of patients with metastatic or recurrent locally advanced nasopharyngeal carcinoma. The drug was also approved on Monday as a single agent — that means given alone — for patients with unresectable, recurrent or metastatic nasopharyngeal carcinoma that got worse on or after platinum-based chemotherapy. 

The Loqtorzi/chemotherapy combination was based off findings from the JUPITER-02 trial, while the POLARIS-02 trial led to the single-agent approval. The former found that the Loqtorzi-containing regimen improved progression-free survival (time from treatment until disease worsens or death) compared to placebo plus the chemo drugs, while the latter showed improved response rates with Loqtorzi. 

FDA Approves Keytruda Plus Chemo for Locally Advanced, Metastatic Biliary Tract Cancer 

On Wednesday, the FDA approved the immunotherapy drug, Keytruda, plus two chemotherapy drugs — gemcitabine and cisplatin — for the treatment of patients with locally advanced or unresectable metastatic biliary tract cancer. 

Findings from the phase 3 KEYNOTE-966 clinical trial, which showed that overall survival (time from treatment until death of any cause) was better with the Keytruda-containing regimen than it was for the chemotherapy duo alone. Notably, there was no significant difference in progression-free survival between the two regimens. Essentially, that means that patients tended to experience disease worsening at around the same rate or time, however, those in the Keytruda group tended to live longer. Trial results also showed that there was a higher percentage of patients in the Keytruda group whose disease completely disappeared. 

Follow-Up Exams More ‘Tolerable’ With Sexual Activity After Cervical Cancer


In the gynecologic cancer space, recent research presented at the American Society for Radiation Oncology Annual Meeting found that cervical cancer follow-up appointments may be more comfortable or tolerable for patients who are sexually active. 

CURE® spoke with one of the study authors, Dr. Kathrin Kirchheiner, who mentioned that sexual activity is by no means necessary for this patient population. She understands that the disease and its treatments can affect libido or make sex physically uncomfortable. However, if patients with gynecologic cancer are experiencing sexual side effects, they should certainly bring it up to their health care providers. 

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Meet Dr. Ulka Vaishampayan* – an oncologist and leading expert in treating people with kidney cancer, including renal cell carcinoma (RCC) which is the most common type of kidney cancer in adults.

She understands all too well how scary and overwhelming hearing the words “you have cancer” can be for anyone – especially when facing an advanced diagnosis in RCC. In these cases, Dr. Vaishampayan believes that information is power and people can feel better prepared to move forward if they have a support system and strong patient-doctor communication. 

On today’s episode of the Cancer Horizons podcast, Dr. Vaishampayan shares information that's important to understand about RCC and navigating a diagnosis, key questions patients and caregivers should ask their doctor, and insights into a potential dual immunotherapy treatment option for certain patients.

When it comes to making a treatment plan, Dr. Vaishampayan believes in involving her patients closely in the process. “In my practice I tend to explain what options are available to someone, including the pros and cons of each, and I sometimes make a recommendation about a treatment approach if I feel that’s appropriate in their case,” she explains. “I would still explain the reasons for my choice. My intention is that either way it’s a discussion, as it should be a joint or shared decision-making process.”

Terry Broussard**, a man who was diagnosed with advanced RCC, also shares advice from his experience. In Terry’s case, his doctor recommended the dual immunotherapy treatment combination Opdivo® (nivolumab) plus Yervoy® (ipilimumab), which is approved by the U.S. Food and Drug Administration for certain newly diagnosed adults whose kidney cancer has spread (advanced renal cell carcinoma) and have not already had treatment for advanced RCC. It is the first and only combination of two immunotherapies of its kind approved to treat advanced kidney cancer, or RCC.

To learn more, listen to the podcast, visit www.Opdivo.com and see below for Important Safety Information.

*Dr. Vaishampayan is a paid consultant of Bristol Myers Squibb. Dr. Vaishampayan's statements/opinions are those solely of Dr. Vaishampayan and are not necessarily those of Bristol Myers Squibb. Individual results/experiences may vary.

**Terry is an actual patient who has been compensated by Bristol Myers Squibb. Terry's results may not be typical. Medication may not work for everyone.

Indication

OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) to treat adults with kidney cancer in certain people when your cancer has spread (advanced renal cell carcinoma) and you have not already had treatment for your advanced RCC.

It is not known if OPDIVO is safe and effective in children younger than 12 years of age with melanoma or MSI-H or dMMR metastatic colorectal cancer.

It is not known if OPDIVO is safe and effective in children for the treatment of any other cancers.

OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous (IV) use.

Important Safety Information for OPDIVO® (nivolumab) + YERVOY® (ipilimumab)

What is the most important information I should know about OPDIVO + YERVOY?
OPDIVO and YERVOY are medicines that may treat certain cancers by working with your immune system. OPDIVO and YERVOY can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. These problems may happen anytime during treatment or even after your treatment has ended. You may have more than one of these problems at the same time. Some of these problems may happen more often when OPDIVO is used in combination with another therapy.

Call or see your healthcare provider right away if you develop any new or worse signs or symptoms, including:

Lung problems: new or worsening cough; shortness of breath; chest pain

Intestinal problems: diarrhea (loose stools) or more frequent bowel movements than usual; stools that are black, tarry, sticky, or have blood or mucus; severe stomach-area (abdominal) pain or tenderness

Liver problems: yellowing of your skin or the whites of your eyes; severe nausea or vomiting; pain on the right side of your stomach area (abdomen); dark urine (tea colored); bleeding or bruising more easily than normal

Hormone gland problems: headaches that will not go away or unusual headaches; eye sensitivity to light; eye problems; rapid heart beat; increased sweating; extreme tiredness; weight gain or weight loss; feeling more hungry or thirsty than usual; urinating more often than usual; hair loss; feeling cold; constipation; your voice gets deeper; dizziness or fainting; changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness

Kidney problems: decrease in your amount of urine; blood in your urine; swelling in your ankles; loss of appetite

Skin problems: rash; itching; skin blistering or peeling; painful sores or ulcers in the mouth or nose, throat, or genital area

Eye problems: blurry vision, double vision, or other vision problems; eye pain or redness.

Getting medical help right away may help keep these problems from becoming more serious. Your healthcare team will check you for these problems during treatment and may treat you with corticosteroid or hormone replacement medicines. Your healthcare team may also need to delay or completely stop your treatment if you have severe side effects.

Possible side effects of OPDIVO + YERVOY

OPDIVO and OPDIVO + YERVOY can cause serious side effects, including:

Severe infusion reactions. Tell your healthcare team right away if you get these symptoms during an infusion of OPDIVO or YERVOY: chills or shaking; itching or rash; flushing; shortness of breath or wheezing; dizziness; feel like passing out; fever; back or neck pain

Complications, including graft-versus-host disease (GVHD), of bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be severe and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with OPDIVO or YERVOY. Your healthcare provider will monitor you for these complications.

The most common side effects of OPDIVO, when used in combination with YERVOY, include: feeling tired; diarrhea; rash; itching; nausea; pain in muscles, bones, and joints; fever; cough; decreased appetite; vomiting; stomach-area (abdominal) pain; shortness of breath; upper respiratory tract infection; headache; low thyroid hormone levels (hypothyroidism); constipation; decreased weight; and dizziness.

These are not all the possible side effects. For more information, ask your healthcare provider or pharmacist. You are encouraged to report side effects of prescription drugs to the FDA. Call 1-800-FDA-1088.

Before receiving OPDIVO or YERVOY, tell your healthcare provider about all of your medical conditions, including if you:

Females who are able to become pregnant:

Your healthcare provider should do a pregnancy test before you start receiving OPDIVO or YERVOY.

Tell your healthcare provider about all the medicines you take, including prescription and over-the- counter medicines, vitamins, and herbal supplements.

Please see U.S. Full Prescribing Information and Medication Guide for OPDIVO and YERVOY.