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CURE’s gynecologic cancer page is an extensive resource of cancer information featuring the latest gynecologic cancer news, expert oncologist insights on the latest cancer treatments, oncology research, advocacy efforts, and medical data on gynecologic cancer.

This week in oncology news, we saw a few decisions from the Food and Drug Administration, ranging from the agency agreeing to review a drug and potentially grant it a full approval to their citing manufacturing concerns for a gastric cancer drug.

Additionally, a small study showed 100% disease control rate in a subtype of non-Hodgkin lymphoma, and a clinical evaluation of a new prostate cancer drug will continue to enroll patients.

FDA Accepts sBLA For Tivdak in Recurrent or Metastatic Cervical Cancer

The Food and Drug Administration has accepted a supplemental Biologics License Application (sBLA) to Tivdak for the treatment of patients with recurrent or metastatic cervical cancer that has progressed after first-line therapy. Tivdak, the first antibody-drug conjugate for this patient population, received accelerated approval in 2021. Now, the sBLA is for the continued approval, which is contingent upon clinical benefit verification in confirmatory trials.

Results from the phase 3 innovaTV 301 trial presented at the 2023 ESMO Congress demonstrated that Tivdak reduced the risk of death by 30% compared to chemotherapy as a second- or third-line treatment for this patient population. The trial also showed improvements in overall survival, progression-free survival, and confirmed objective response rate. Treatment-related side effects were observed in a majority of patients, with anemia and nausea being the most common.

The FDA plans on making a decision on the approval by May 9, 2024.

FDA Cites Manufacturing Concerns in Missed Gastric Cancer Drug Deadline

Also in FDA news from the week, the agency will not meet the Jan. 12, 2024, deadline for approving zolbetuximab, a drug designed for the treatment of unresectable or metastatic HER2-negative, CLDN 18.2-positive gastric or gastroesophageal junction adenocarcinoma.

The FDA attributed the delay to "unresolved deficiencies following its pre-license inspection of a third-party manufacturing facility" and issued a complete response letter to Astellas, clarifying that no clinical concerns, including safety and efficacy, were identified.

Zolbetuximab, a monoclonal antibody targeting the CLDN 18.2 protein overexpressed in certain gastric cancers, has shown promise in preclinical studies by inducing cell death in cancer cells. The drug had received a priority review from the FDA based on positive outcomes in the phase 3 SPOTLIGHT clinical trial and the GLOW clinical trial. Astellas, the manufacturer of the drug, is now collaborating with the FDA and the third-party manufacturer to address the identified issues and establish a timeline for resolving them.

Enrollment Continues in Study Evaluating ONCT-534 For Advanced Prostate Cancer

Patients are still being enrolled in an assessment of the novel drug, ONCT-534, for the treatment of advanced prostate cancer that has relapsed or is refractory to approved androgen receptor pathway inhibitors (ARPIs).

The study's first two cohorts received daily oral doses of 40 mg and 80 mg of ONCT-534, while the third and fourth patients, part of the third cohort, will be administered a 160 mg daily oral dose.

The ongoing phase 1/2 ONCT-534-101 study aims to determine the drug's safety, tolerability and preliminary antitumor activity, with a total of 27 patients in the first phase and two cohorts of 16 patients each in the second phase.

The study is anticipated to conclude in January 2028.

Novel Drug Shows 100% Disease Control Rate in WM

And finally, a novel drug, iopofosine I 131, showed a 100% disease control rate in patients with Waldenstrom’s macroglobulinemia, according to topline findings from the CLOVER WaM study.

The CLOVER WaM trial investigated iopofosine I 131 in 50 WM patients who had undergone at least two prior lines of therapy, including a BTK inhibitor. In an efficacy evaluable population of 41 patients who received a total dose of 60 mCi 60 or more days ago, the trial met its primary endpoint with a major response rate of 61%. The overall response rate in evaluable patients was 75.6%, with 100% experiencing disease control and 76% not experiencing disease progression at an average follow-up of eight months. Notably, 8% of patients achieved a stringent complete remission.

Now we should note, however, that this is a small study sample size of only 50 patients, so we would expect to see future studies evaluating this drug in a larger patient population.

For more news on cancer updates, research and education, don’t forget to 

Last week, the FDA provided updates on two cancer therapies. In this episode, we discuss those decisions and more. 

FDA Gives Cancer Drug Updates, Prostate Cancer Trial Enrolls Patients 

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.

CURE® editors take a look back on last week’s major oncology headlines, from the cancer drug shortage to FDA approvals and the potential benefit of sexual activity for cervical cancer survivors. 

An Update on the Cancer Drug Shortage, FDA Approvals and Cervical Cancer

Rina-S earned breakthrough therapy designation for patients with advanced endometrial cancer whose disease has worsened after platinum-based chemotherapy.

Rina-S Earns Breakthrough Designation in Advanced Endometrial Cancer

I wrote a poem about life with endometrial cancer, rejecting pity and embracing strength, connection and the dignity of being truly seen.

Please Don’t Call Me ‘Dear’: A Poem From Cancer Treatment

Thirteen years after cervical cancer, I’ve found strength in healing, grief in silence, and hope in sharing the quiet truths of survivorship.

Finding Strength During Life After Cervical Cancer

Rina-S led to a 50% response rate, including two complete responses, in heavily pretreated advanced endometrial cancer, according to early trial findings.

Rina-S Yields 50% Response Rate in Advanced Endometrial Cancer

Dr. Ritu Salani discussed Cervical Cancer Awareness Month, highlighting what patients with this disease should be aware of as well as prevention tactics.

Driving Awareness, Action and Empowerment During Cervical Cancer Awareness Month

Natalie Schnaitmann discusses urgent supportive care gaps younger women with cancer encounter, and how they affect long-term quality of life.

Understanding Supportive Care Needs in Younger Women With Cancer

Young women with cancer are in need of more individualized supportive care in order to best meet each patients unique needs, ranging from fertility preservation to financial concerns, according to Natalie Schnaitmann, executive director of the Department of Supportive Care Medicine at City of Hope, located in Duarte, California.

To further discuss this topic, Natalie sat down for an interview with CURE in which she expanded on the most urgent supportive care gaps younger women with cancer encounter, and how they affect long-term quality of life for patients in this space.

I would say it's hard to identify what's most urgent for a patient and family, because whatever supportive care gap they are experiencing, it is urgent to them. Through screening and working with tens of thousands of patients, we understand the common needs that arise, and it's important for us to address those upfront. Since it's often their first time facing cancer, we know the right questions to ask regarding their practical, social, emotional, and physical supportive care needs. However, it's crucial to personalize this for the individual patient and family sitting right in front of you, asking the right questions to uncover what is most concerning for them.

For young women in particular, which is our current focus, fertility preservation is an extremely important topic. It's vital to bring this up early, asking questions in a way they can understand the consequences, opportunities, and implications. However, this young patient population isn't only comprised of women who haven't had children yet. Some young women may have already completed their families, making fertility not their top concern. They might be dealing with parenting, often young children, and perhaps already balancing a demanding career, which is challenging enough without adding cancer and its treatment.

While fertility might not be their focus, addressing parenting issues becomes critical. This includes basic concerns like: “How am I going to get myself to treatment when I'm feeling terribly ill and immunocompromised?” Or, if they have a partner who needs to work and can't safely use public transportation, fundamental questions arise: “Who's going to watch the kids when I'm gone? Who's going to take them to school or soccer practice when I have an eight-hour chemotherapy session or am hospitalized?” These are very difficult, day-to-day practical questions that can become significant barriers to care for young women.

Beyond the scope of children, not everyone is dealing with those specific issues. You might have a young couple. We have a special “Couples Coping Together Against Cancer” program, recognizing the incredible strain any couple experiences going through this together. Young couples sometimes have fewer years of building their stress tolerance together. Finances can also be a really big deal for younger individuals, impacting their ability to work, especially if their career or insurance depends on that work. That's a lot.

Transcript has been edited for clarity and conciseness.

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Dr. Ritu Salani shared her advice for patients undergoing advanced treatment options for their cervical cancer who are experiencing side effects.

An Expert Shares Her Advice For Managing Side Effects in Cervical Cancer

During January, Cervical Cancer Awareness Month, it is important to bring awareness to the disease’s treatment landscape. A vital aspect of cervical care for patients to be aware of is side effects, and the mitigation of these side effects.

In an interview with CURE®, Dr. Ritu Salani shared her advice for patients undergoing advanced treatment options for their cancer — such as immunotherapy or other targeted options — and emphasized the importance of always speaking with your health care team.

Salani currently serves as the Director of Gynecologic Oncology at the University of California, Los Angeles (UCLA), UCLA Health, and is a board-certified gynecologic oncologist. Don't forget to read our full interview with her on Cervical Cancer Awareness Month!

The best thing is to speak with your doctor and your medical care team about what side effects to potentially expect and to monitor for it. Sometimes we tolerate side effects a little bit better when we know that the cancer treatment is working or doing its job; however, we can also help mitigate or reduce some of these side effects like diarrhea, nausea and pain.

There's a lot of things that we can do, so having that open dialogue with your healthcare team is going to be really important. For many patients, [the healthcare team may consist of] gynecologic oncologists, allied health professionals such as physician assistants or nurse practitioners, nursing staff, radiation oncologists and medical oncologists. Overall, it is a team of people that are there to work with you.

The other thing to think about [is to not] be ashamed or shy to report your symptoms. It is important that we know this, as keeping [patients] on an effective therapy is one of the most important things, and if side effects develop, we may have to reduce or delay treatment, but not stop it. That's important because if we can help you stay on treatment longer, even if it's with a slow, slight delay or a reduced dose, it's still getting the therapy, and that can be key to treating your cancer.

Transcript was edited for clarity and conciseness.

Dr. Balazs Halmos discusses the significance of the FDA approval of the subcutaneous injection formulation of Opdivo for patients with solid tumors.

Delving into Subcutaneous Versus Intravenous Opdivo in Solid Tumors

approval of the subcutaneous injection formulation of Opdivo Qvantig

 (nivolumab and hyaluronidase-nvhy) for patients with solid tumors has the potential to benefit patients in many ways, according to Dr. Balazs Halmos, who adds that this may be a significant advancement for patients eligible for treatment.

“Traditionally, this medicine has to be given through the IV [intravenous], and it's nice to see a new wave of improving the quality of care for patients by allowing some of these medicines to be given subcutaneously, meaning under the skin,” he stated in an interview with CURE®.

In the interview, he delved into detail on the significance of this FDA approval for patients with solid tumors who may be treated with Opdivo, as well as explained the benefits that are offered with treatment of subcutaneous versus IV Opdivo.

Halmos is a Professor in the Department of Oncology (Medical Oncology) and in the Department of Medicine (Oncology & Hematology) at the Albert Einstein College of Medicine, as well as an Associate Director of Clinical Science at the Montefiore Einstein Comprehensive Cancer Center, located in New York, New York.

This is one of those medicine’s that we've been very successfully using for a decade in many different cancer types. This medicine, Opdivo, is based on a discovery that led to a Nobel Prize and is one of those immune checkpoint inhibitors that can re-energize the immune system's ability to fight different cancers as foreign elements in our bodies. This is a very successful drug. We use it frequently in the management of different types of lung, skin and gynecological cancers.

Of course [this approval of subcutaneous Opdivo is] still an injection, but it's an injection that can be quicker, more convenient, and for some patients, potentially less painful. It also allows for a lot of time savings in the physician's offices. [For example], maybe there's not a need to wait for an infusion chair. From that standpoint, it's not a major advance for the field, but it could be a significant advancement for any given patient who needs some of these treatments. That's what this approval is about.

An oncology nurse explained the impacts that organizations like Wonders & Worries can make on children of patients with cancer. 

Child-Focused Organizations Give Parents With Cancer ‘One Less Stress’

Sometimes when patients receive a cancer diagnosis, they are equally — if not more so — concerned with their children’s wellbeing than their own treatment. Luckily, there are resources out there that can provide support for children and teens whose parents have cancer, explained Meaghan Mooney.

Mooney, who is the chief of staff at Ascension Medical Group in Austin, was the recipient of the 

2024 Extraordinary Healer® Award for oncology nurses

. She was nominated by Meredith R. Cooper, cofounder of the Wonders & Worries organization. The Austin-based organization provides developmental and coping support to children who have a parent facing a major medical issue, such as cancer. Mooney serves on the board of the organization, and as an oncology nurse, has seen first-hand the stress that cancer can put on an entire family, and how groups like Wonders & Worries can help.

Extending Healing Commitment to a Cancer Community

“It was just [that] so many of them — especially with [gynecologic] oncology — [there are] a lot of moms that we were dealing with,” Mooney said in an interview with CURE®. “They just expressed it was just one less stress they had to worry about. They were more worried about their kids rather than their own treatment.”

Wonders & Worries is a nonprofit based in Austin … They use child life specialists to provide support services for children whose parents have a serious illness. [For the] majority of the clients we serve, it's a cancer diagnosis. So they will explain the disease in an age-appropriate manner. They provide counseling services and bereavement services if needed.

I’ve actually had several patients who utilize their services, and I saw the impact that Wonders & Worries made on them and their family. It was just [that] so many of them — especially with [gynecologic] oncology —[there are] a lot of moms that we were dealing with. They just expressed it was just one less stress they had to worry about. They were more worried about their kids rather than their own treatment. … They would often say that they felt more comfortable [after utilizing Wonders & Worries’ services], and it was one less weight off their shoulders that they didn't have to worry about because they knew their kids were taken care of.

I joined their board, goodness, about five years ago. So I've been on their board. I've served on several committees. I've been their gala chair for the past couple years. I've helped with outreach, fundraising, lots of different things to kind of help kind of spread those services and make because it was extremely valuable and a very overlooked aspect of oncology care because so many people are focused on the patient. But there's more to the patient than just them.

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Adding Keytruda to chemotherapy improved survival outcomes in patients with endometrial cancer, regardless of their mismatch repair or PD-L1 status. 

Keytruda Combo Beneficial ‘Irrespective of PD-L1’ in Endometrial Cancer

Keytruda (pembrolizumab) plus chemotherapy improved survival in patients with endometrial cancer, according to findings from the phase 3 NRG-GY018/KEYNOTE-868 trial presented at the 2024 

The drug combination tended to improve overall survival (time from treatment until death of any cause) and progression-free survival (time from treatment until death or disease worsening). Researchers observed these findings were seen across disease subtypes, including patients with DNA mismatch repair-proficient and -deficient disease, as well as those with or without PD-L1 positivity.

Keytruda is an immunotherapy drug that works by blocking the interaction between the PD-1 and PD-L1 proteins. In doing so, the drug eliminates the cancer cells’ ability to hide from the immune system. Interestingly, the NRG-GY018 trial demonstrated benefits from Keytruda regardless of their cancer’s PD-L1 expression, explained study author, Dr. Ramez N. Eskander, assistant professor of obstetrics, gynecology and reproductive sciences at the University of California San Diego Health.

“The relevance of PD-L1 molecular testing in endometrial cancer really has not been established, meaning the therapeutic information it may provide us to make a therapeutic decision has not been adjudicated or determined,” Eskander explained in an interview.

The relevance of PD-L1 molecular testing in endometrial cancer really has not been established, meaning the therapeutic information it may provide us to make a therapeutic decision has not been adjudicated or determined. There are some clinical trials, I will say the DUO-E trial, which suggested that utilizing their assay, which was a TAP score, may inform benefit, although when we looked at this and NRG-GY018, and [also] in prior endometrial cancer trials looking at immunotherapy, we didn't see that PD-L1 expression status informed efficacy. In the RUBY trial, when they presented data at this annual meeting, SGO 2024, similarly, they did not see that PD-L1 expression by a [combined positive score] informed the therapeutic benefit of immunotherapy.

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