Following the August 2024 decision by the FDA to 

expand the approval of dostarlimab-gxly (Jemperli) plus chemotherapy

 to include the frontline treatment of patients with primary advanced or recurrent endometrial cancer, patients now have greater choice in terms of effective therapies in the first-line setting, according to Dana M. Chase, MD.

The expanded FDA approval indicated dostarlimab plus carboplatin and paclitaxel, followed by single-agent dostarlimab for the treatment of adult patients with primary advanced or recurrent endometrial cancer. The regimen was previously approved in primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H). The expanded approval was supported by data from the phase 3 RUBY trial (NCT03981796), which demonstrated that patients who received dostarlimab plus chemotherapy in the overall population achieved a median overall survival (OS) of 44.6 months (95% CI, 32.6-not reached) compared with 28.2 months (95% CI, 22.1-35.6) among those who received placebo plus chemotherapy (HR, 0.69; 95% CI, 0.54-0.89; 1-sided 

“Based on [data from] the RUBY trial, we [can] use the dostarlimab with carboplatin/paclitaxel, followed by the dostarlimab maintenance in all comers, [including] patients [with disease] that is proficient mismatch repair [pMMR]or dMMR,” Chase explained in an interview with 

® during Gynecologic Cancer Awareness Month, observed annually in September. “We can use it for everybody, and that’s helpful in that we have more options for our patients.”

Chase is a professor of clinical obstetrics and gynecology in the Division of Gynecologic Oncology at The University of California, Los Angeles (UCLA) Health in Los Angeles, California.

In the interview, Chase discussed the current treatment landscape of the disease, additional data from the RUBY trial, and the significance of the awareness month.

How do you typically treat patients with recurrent endometrial cancer?

: When you have a patient with recurrent endometrial cancer, it’s helpful to know what the characteristics of their cancer are. These days, the biomarker profile of the endometrial cancer is important. Is it pMMR? Is it dMMR? Is it HER2 2+ or 3+? Is it p53 wild type or mutated?

It’s also important to know when their last therapy was and what their last therapies were. Have they gotten immunotherapy previously? Was their last chemotherapy 6 months ago, 3 months ago, or 12 months ago?

There are a lot of different factors that play into how you’re going to treat that recurrent endometrial cancer. Even 10 or 15 years ago, it was probably that we would just treat these patients all the same way, with the same chemotherapies, the same approach to sequencing and treatment. However, these days, we’ve been able to really refine the recommended treatments based on the biomarker profile and the patient’s previous therapies.

How do you determine whether to add chemotherapy to an immunotherapy regimen for patients with recurrent disease?

If this is the patient’s first recurrence, and let’s say the patient previously had radiation alone, meaning they didn’t get chemotherapy at all, they’re new to chemotherapy. In that situation with recurrent disease that’s not amenable to another surgery or to radiation treatment, that patient I would treat with carboplatin/paclitaxel, and I would consider the addition of immunotherapy. The addition of an immunotherapy agent is very important for patients who are deficient in mismatch repair proteins. For patients that are dMMR, I would definitely approach that patient with treating them with carboplatin, paclitaxel, and an immunotherapy agent. There are two immunotherapy agents that are both anti–PD-1 antibodies. One is pembrolizumab [Keytruda], and the other is dostarlimab. I would choose between one of those to add to the carboplatin/paclitaxel in recurrent disease.

Now, it becomes a little trickier when the patient has already had chemotherapy. Let’s say they had carboplatin/paclitaxel, and this is their first recurrence, and they’ve been exposed to chemotherapy previously. In that situation, for a dMMR patient, if they’ve never had immunotherapy, it’s a no-brainer for me. I would give them carboplatin/paclitaxel, and I would add either dostarlimab or pembrolizumab. Now, if that patient is a pMMR patient and they’ve gotten carboplatin/paclitaxel before, your options are to give them carboplatin/paclitaxel again and possibly add an immunotherapy to that doublet therapy, meaning dostarlimab or pembrolizumab. Or there’s another option for those patients, which is to treat them with pembrolizumab and Lenvatinib [Lenvima]. Pembrolizumab plus lenvatinib is a non-chemotherapy option for that pMMR patient, and that’s helpful, because many times these patients who’ve gotten carboplatin and paclitaxel previously don’t want to get chemo again. They don’t want to lose their hair again. They don’t want to feel as tired or as sick—get neuropathy, for example. Those are the 2 considerations that might drive that patient to get lenvatinib and pembrolizumab.

The treatment of recurrent disease and adding immunotherapy to it depends on the patient’s profile. When was their last chemotherapy? What are their biomarkers? What are the tumor characteristics? What adverse effects did the patient have previously that they’re still potentially carrying from their last treatment?

What were the notable data from the RUBY trial?

RUBY was a randomized phase 3 trial, and the patients were randomized to carboplatin/paclitaxel with dostarlimab, followed by dostarlimab maintenance for up to 3 years, vs carboplatin/paclitaxel with a placebo, followed by a placebo for up to 4 years. One of the primary efficacy end points was OS and progression-free survival [PFS] in the all-comer group—so in everybody, dMMR and pMMR combined. Another primary efficacy end point was to look specifically at the dMMR patients and what their PFS was.

On that trial, we saw statistically significant improvements in both PFS and OS in the overall population, and we saw significant improvements in PFS in the dMMR group. What’s pretty incredible about the results is that once those survival curves start to separate, they maintain that separation. That difference between the 2 arms is maintained over time, and there’s now over 3 years of follow-up data to go by.

Other important characteristics of that trial are that it included high-risk histologies. It included carcinosarcoma patients, it included serous, it included clear cell, and it included mixed histologies, including dedifferentiated types. In addition, it included patients who had had chemotherapy only 6 months ago. The treatment-free interval had to be at least 6 months, but some of those patients had a relatively short treatment-free interval.

What else is interesting about the trial is that while most of the patients had to have measurable disease after surgery—for example, if it was a primary advanced, not a recurrent patient—if they had surgery, most of them had to have measurable disease. However, on the trial, there were some patients who did not have measurable disease. For example, if [a patient] had stage IIIC [disease] but they had a high-risk histology like carcinosarcoma, clear cell, or serous, they did not have to have measurable disease after surgery. Or if they had endometrioid type, and they had positive para-aortic nodes at the time of surgery, they did not have to have measurable disease. Unlike some of the other trials, there were some patients—not a ton of them, but some—with non-measurable disease.

How has the expanded FDA approval of dostarlimab affected your clinical practice?

For me, it’s a no-brainer to use it in a dMMR patient if they have advanced disease and this is their first treatment, or if they have recurrent disease and they’ve had either previous chemotherapy or not. For that dMMR patient, it’s a no-brainer for me to use carboplatin/paclitaxel and dostarlimab—or pembrolizumab, because that’s another option that we have.

For the pMMR patient, it becomes a little more nuanced. Although I have this option to use carboplatin/paclitaxel and immunotherapy—either dostarlimab or pembrolizumab—for the pMMR patient, it’s more of a shared decision-making process with the patient. Based on the GY018 trial, there was a significant improvement in PFS in the pMMR patients. Based on the RUBY trial, although it was an exploratory analysis, it looked like there was a significant improvement in PFS in the pMMR patients as well. Therefore, there is an improvement in outcomes in those patients. The question is whether or not that’s clinically significant, and that’s a discussion I’ll have with the patient: How much of a clinical benefit are they ok with to add this additional treatment to their regimen that might have toxicity? For the pMMR patient, it’s great to have options, but it’s more of a shared decision-making process.

What is the importance of recognizing Gynecologic Cancer Awareness Month, particularly regarding endometrial cancer?

It is Gynecologic Cancer Awareness Month in September, and it’s great that we have new therapies for our patients with endometrial cancer. It’s great that for some of our patients, we’re improving survival. Nevertheless, we also have to remember that it’s one of the cancers that’s on the rise. It’s the fourth most common cancer in women, but it’s on its way to surpassing colon cancer and become the third most common cancer in women.

In addition, it’s become even more deadly than ovarian cancer. It’s now in the top 10 most deadly cancers in women. We are seeing that certain patients are more likely to die of endometrial cancer than others. Raising awareness about the symptoms of endometrial cancer is important. Patients need to know, for example, it’s not normal to have bleeding after menopause—even if it’s just a spot or a pinkish discharge. That’s not normal. They should go see a doctor and tell them about their symptom, even if it’s just once.

It’s very important to educate postmenopausal women that any bleeding is abnormal post-menopause. For premenopausal women, if they’ve had a certain pattern of their menstruation their whole life, and that changes—like all of a sudden they’re having more bleeding or heavier periods or bleeding in between periods—that’s also a reason to go see the gynecologist. That’s not something to ignore.

I believe it’s important to spread the word about the symptoms so we can hopefully continue to see women present in an early stage as opposed to an advanced stage. Additionally, there is an association between obesity and endometrial cancer. Women who are obese, meaning they have a BMI over 30, are at higher risk for endometrial cancer. Anything that we can do to reduce obesity in the United States should hopefully also help reduce the accelerated incidence of endometrial cancer.

FDA expands endometrial cancer indication for dostarlimab-gxly with chemotherapy. FDA. August 1, 2024. Accessed September 23, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-expands-endometrial-cancer-indication-dostarlimab-gxly-chemotherapy

Jemperli. Prescribing information. GlaxoSmithKline; 2021. Accessed September 23, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761174s010lbl.pdf

Articles

Dana M. Chase, MD, discusses the effect of the frontline dostarlimab plus chemotherapy on the recurrent endometrial cancer landscape.

Dostarlimab Plus Chemo Expands Frontline Options in Advanced/Recurrent Endometrial Cancer

The integration of immunotherapy with standard chemotherapy regimens has established a new and effective standard of care regimen for patients with advanced or recurrent endometrial cancer, according to Brian Slomovitz, MD. Although these treatment advancements are important to communicate, it is critical to increase awareness of next steps for improving patient outcomes and disease prevention efforts in the field of gynecologic oncology, he said.

“Part of our job as clinicians who treat this disease is not only to come up with the best treatment options but to help educate our patients and our colleagues about better ways to treat cancer and even better ways to prevent it,” Slomovitz shared in an interview with 

during Gynecologic Cancer Awareness Month, which is marked in September. “It is really an exciting time [in gynecologic cancer research], especially regarding [disease] prevention.”

In the interview, Slomovitz discussed the benefits seen with chemoimmunotherapy combinations for patients with recurrent or advanced endometrial cancer regardless of mismatch repair (MMR) status; the essential role of universal biomarker testing to guide personalized treatment decisions in recurrent disease; and the importance of educating patients about how weight impacts the risk of endometrial cancer.

Slomovitz is the director of gynecologic oncology and cochair of the Cancer Research Committee at Mount Sinai Medical Center, and a professor of obstetrics and gynecology at Florida International University in Miami. 

: What is your typical treatment decision-making process for recurrent endometrial cancer, and what factors influence this choice?

There are a lot of new treatment options for patients with recurrent or advanced endometrial cancer. One of them, and foremost, is incorporating immunotherapy with chemotherapy in the management of the disease. We found that for all endometrial cancer patients, regardless of the biomarker profiling, there is a benefit [with this approach]. Patients with MMR-deficient tumors are [generally] much more responsive to immunotherapy. However, even those tumors with MMR-proficient [tumors] do respond well when adding immunotherapy to traditional chemotherapy.

We also look at other factors. For example, we consider whether patients may benefit from hormonal therapy, or if other biomarkers that are overexpressed in the tumors—for example, HER2—as a means of potential targets that we can exploit.

In which scenarios would you incorporate immunotherapy into a chemotherapy regimen?

When we talk about what type of treatment we are going to use for recurrent cancers, the backbone in the past has always been carboplatin and paclitaxel. Now, we are really doing, or at least educating [other about], universal biomarker testing. That biomarker testing will help delineate the MMR status—is it deficient or proficient? This is also similar to microsatellite instability or stability and other markers that we are looking at. For most patients, unless they have another contraindication, we would consider using that treatment.

What pivotal findings from part 1 of the phase 3 RUBY trial (NCT03981796) supported the 

FDA approval of dostarlimab plus chemotherapy

 for the "all-comer" population of patients with primary advanced or recurrent endometrial cancer?

Part 1 of RUBY is a study [evaluating] chemotherapy plus or minus dostarlimab-gxly [Jemperli] in women with advanced or recurrent endometrial cancer in the first-line setting.

 It [randomly assigned] patients to receive either dostarlimab [(n =245) or placebo (n = 249)] with their chemotherapy. Those patients who received dostarlimab experienced improved progression-free survival in the "all-comer" population [vs chemotherapy alone. (HR, 0.64; 95% CI, 0.51-0.80; 1-sided 

 < .0001)]. [There were] also suggestions of an overall survival benefit [with dostarlimab plus chemotherapy] in all populations [HR, 0.69; 95% CI, 0.54-0.89; 1-sided 

We now have more prolonged data in this setting that reconfirms the earlier findings. The farther out we go, we are still seeing that benefit. The data are really more mature for the RUBY than some of the other studies [in this space].

How has this expanded approval affected your practice? Are there any particular benefits or challenges associated with using dostarlimab in this broader patient population?

In general, based on the data from RUBY, the phase 3 NRG-GY018 (NCT03914612), and even the phase 3 DUO-E trial (NCT04269200), we know that immunotherapy plays a role in the management of this disease. I use several different regimens in my practice. The RUBY trial, in particular, allowed [patients with] carcinosarcomas [to enroll], where the other studies didn't necessarily allow for that. There was also a subpopulation of patients who are going to be treated in what we call the adjuvant setting, which was nicely included in the RUBY trial. This makes it stand out.

I am currently using dostarlimab in combination with chemotherapy for my patients with disease, amongst other regimens. I am also a clinical trialist. Not only are we looking to see what the next greatest therapies are, but we need to compare them with the current best therapies. With all these advances, we moved immunotherapy and chemotherapy into the control arm of the studies that are ongoing now and that we are writing now, because it is [clear] that this is the best [available] therapy [that new regimens should be compared against]. Now we need to do better than that.

What are some ongoing trials or emerging agents of interest in the field of gynecologic oncology?

We are excited for the upcoming [2025] ESMO [Congress] in Berlin, as well as the IGCS 2025 Annual Global Meeting in Gynecologic Oncology this November. We are anticipating a lot of good data [to emerge from those meetings. We are looking at more ways to [leverage] immunotherapy, not just in endometrial cancer, but in ovarian cancer as well.

There are also going to be some data presented at these meetings [with] non-chemotherapy, non-immunotherapy [options] for treating this disease. We are excited to hear about some of the latest data that are going to come out in that setting.

What is the importance of recognizing Gynecologic Cancer and Endometrial Cancer Awareness Month?

Gynecologic Cancer Awareness Month is a great time for us to get out there and talk about the cancer, talk about what the next steps are to get better outcomes for our patients, [discuss] what the next steps are with the standard of care, and [outline] where we are going with some of our research.

But we can't talk about treatment without [discussing] prevention. We need to educate our patients about obesity. A recent article that came out [showing whether] weight loss with the GLP-1 [glucagon-Like peptide-1] medications, like semaglutide [Ozempic] can decrease the risk of endometrial cancer. We could talk about the next, latest, and greatest therapies, which is always exciting, but [it would be even better] if we could prevent [this disease]. Reassuring ourselves that weight loss could help prevent cancer—these are the things that we love to talk about during this month, not just the new immunotherapies or the latest surgery that we are doing.

FDA expands endometrial cancer indication for dostarlimab-gxly with chemotherapy. FDA. August 1, 2024. Accessed August 23, 2024. 

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-expands-endometrial-cancer-indication-dostarlimab-gxly-chemotherapy

Ryan C. FDA approves expanded indication for dostarlimab plus chemo in primary advanced or recurrent endometrial cancer. 

. August 1, 2024. Accessed September 22, 2025. https://www.onclive.com/view/fda-approves-expanded-indication-for-dostarlimab-plus-chemo-in-primary-advanced-or-recurrent-endometrial-cancer

Brian Slomovitz, MD, spotlights key advancements in disease management and prevention during Gynecologic Cancer Awareness Month.

Spotlighting Disease Prevention Efforts Alongside Treatment Breakthroughs Is Crucial for Endometrial Cancer Risk Reduction

Dr Chase on the Importance of Endometrial Cancer Awareness Month

Dr Chase on the Importance of Endometrial Cancer Awareness Monthment in Gynecologic Oncology  

"It's great that we have new therapies for our [patients with] endometrial cancer…and that for some patients, we're really improving survival. However, we have to remember that it's one of the cancers on the rise…so raising awareness about the symptoms of endometrial cancer are really important."

Dana M. Chase, MD, a professor of clinical obstetrics and gynecology in the Division of Gynecologic Oncology at UCLA Health, noted the rising incidence of endometrial cancer, its deadly nature, and the importance of clinical trials for advancing treatment options.

Chase stated that although new therapies are available and are improving survival for some patients with endometrial cancer, the disease itself is a growing concern. Endometrial cancer is currently the fourth most common cancer in women but is on track to surpass colon cancer and become the third most common cancer in women in the United States, Chase reported. Furthermore, it has become more deadly than ovarian cancer, positioning it in the top 10 most deadly cancers in women, she added.

To combat these trends, Chase stressed the crucial importance of raising awareness about the symptoms of endometrial cancer. She noted that in certain groups, patients are more likely to die of the disease. For postmenopausal women, Chase emphasized that any bleeding is abnormal, even if it is just a spot or a pinkish discharge, and clinicians should be aware of these symptoms. For premenopausal women, a change in the typical pattern of menstruation—such as having more bleeding, heavier periods, or bleeding in between periods—is a reason to consult a gynecologist and should not be ignored, she advised. Chase concluded that spreading the word about these symptoms is vital so that women can present in an early stage, rather than an advanced stage, of the disease.

Videos

Dana M. Chase, MD, expands on the importance of endometrial cancer awareness month, which is observed annually in September.
 


Slomovitz

“Part of our job as [oncologists] is not only to come up with the best treatment options, but to help educate our patients and our colleagues about better ways to manage cancer and even better ways to prevent cancer.”

Brian Slomovitz, MD, the director of Gynecologic Oncology and co-chair of the Cancer Research Committee at Mount Sinai Medical Center, as well as a professor of Obstetrics and Gynecology at Florida International University, emphasized the importance of education, prevention, and research in the context of gynecologic cancer awareness month.

Slomovitz began by stating that the responsibilities of an oncologist extend beyond identifying optimal treatment options; they also include educating patients and colleagues on strategies to improve outcomes and reduce incidence of disease.

Endometrial cancer remains the most common gynecologic malignancy in developed countries, with incidence rates continuing to rise in association with modifiable risk factors such as obesity, Slomovitz reported. Prevention should therefore be discussed in parallel with advances in treatment, he emphasized. Recent studies have indicated a potential link between weight management and endometrial cancer risk. Notably, emerging data on GLP-1 receptor agonists like semaglutide show that these agents may contribute to risk reduction through their effects on weight loss, underscoring the opportunity to incorporate prevention-focused discussions into clinical practice.

Beyond prevention, Slomovitz stressed the value of awareness initiatives as platforms to disseminate updates to standards of care and ongoing research. Advances in immunotherapy and surgical techniques have expanded the therapeutic landscape, and gynecologic cancer awareness month serves as a timely reminder of these evolving options. Ensuring that educational efforts encompass the latest developments in systemic therapy, surgical innovation, and biomarker-driven treatment approaches helps ensure that patients benefit from evidence-based, up-to-date care, he stated.

Importantly, gynecologic cancer awareness month also provides an opportunity to reinforce collaboration between oncology specialists, primary care physicians, and the broader healthcare community. Raising awareness among non-specialists can facilitate earlier recognition of symptoms, prompt referral, and timely initiation of therapy.

Although research into immunotherapy combinations and novel systemic agents continues to expand treatment possibilities, equally significant progress can be achieved by addressing modifiable risk factors and engaging patients in proactive discussions on cancer prevention, Slomovitz reiterated. In this way, awareness initiatives serve as a bridge between emerging research, established standards of care, and public health measures aimed at reducing the burden of endometrial cancer, he concluded.

Brian Slomovitz, MD, discusses the importance of education, prevention, and research in the context of gynecologic cancer awareness month.

Dr Slomovitz on the Importance of Education on Disease Management and Prevention During Gynecologic Cancer Awareness Month

, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, 

 covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, we had the pleasure of speaking with Dana M. Chase, MD, about endometrial cancer awareness month, which is observed annually in September. Dr Chase is a professor of clinical obstetrics and gynecology in the Division of Gynecologic Oncology at UCLA Health.

In our exclusive interview, Dr Chase discussed the management of recurrent endometrial cancer, emphasizing the importance of biomarker profiles and previous therapies. For first recurrences, she explained that carboplatin and paclitaxel with pembrolizumab (Keytruda) or dostarlimab-gxly (Jemperli) is recommended for patients with mismatch repair–deficient (dMMR) disease, whereas those with MMR-proficient (pMMR) disease may benefit from carboplatin, paclitaxel, and pembrolizumab (Keytruda) or lenvatinib (Lenvima). She also highlighted findings from the phase 3 RUBY trial (NCT03981796) that supported the FDA approval of dostarlimab, showing significant improvements in progression-free and overall survival in both dMMR and pMMR patients. Chase also noted the rising incidence of endometrial cancer, its deadly nature, and the importance of clinical trials for advancing treatment options.

That’s all we have for today! Thank you for listening to this episode of 

. Check back throughout the week for exclusive interviews with leading experts in the oncology field.

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Dana M. Chase, MD, discusses the management of recurrent endometrial cancer, emphasizing the importance of biomarker profiles and previous therapies. 

Patient Characteristics and Disease Factors Guide the Use of Dostarlimab in Recurrent Endometrial Cancer: With Dana M. Chase, MD

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Raising Awareness About the Expanding Use of Immunotherapy in Recurrent Endometrial Cancer | Supplements and Featured Publications

Dostarlimab Plus Chemo Expands Frontline Options in Advanced/Recurrent Endometrial Cancer

Spotlighting Disease Prevention Efforts Alongside Treatment Breakthroughs Is Crucial for Endometrial Cancer Risk Reduction

Dr Chase on the Importance of Endometrial Cancer Awareness Month

Dr Slomovitz on the Importance of Education on Disease Management and Prevention During Gynecologic Cancer Awareness Month

Patient Characteristics and Disease Factors Guide the Use of Dostarlimab in Recurrent Endometrial Cancer: With Dana M. Chase, MD