HealthDay News — For patients with primary advanced or recurrent endometrial cancer, dostarlimab plus carboplatin-paclitaxel increases progression-free survival vs carboplatin-paclitaxel alone, according to a study published online March 27 in the New England Journal of Medicine.

Mansoor R. Mirza, MD, from Copenhagen University Hospital in Denmark, and colleagues conducted a phase 3, global trial involving patients with primary advanced stage III or IV or first recurrent endometrial cancer who were randomly assigned to receive dostarlimab (500mg) or placebo plus carboplatin and paclitaxel every 3 weeks for 6 cycles, followed by dostarlimab (1000mg) or placebo every 6 weeks for up to 3 years. A total of 494 patients were randomly assigned in a 1:1 ratio; 23.9% had mismatch repair-deficient (dMMR), microsatellite instability-high (MSI-H) tumors.

The researchers found that in the dMMR-MSI-H population, estimated progression-free survival was 61.4 and 15.7% in the dostarlimab and placebo groups, respectively, at 24 months (hazard ratio for progression or death, 0.28). Progression-free survival at 24 months was 36.1 and 18.1% in the dostarlimab and placebo groups, respectively, in the overall population (hazard ratio, 0.64). Overall survival was 71.3 and 56.0% with dostarlimab and placebo, respectively, at 24 months (hazard ratio for death, 0.64). Severe and serious adverse events occurred more often in the dostarlimab group.

“The progression-free survival benefit in the dostarlimab group did not appear to be consistent across all prespecified subgroups,” the authors write.

Several authors disclosed financial ties to pharmaceutical companies, including GSK, which manufactures dostarlimab and funded the study.

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Yu Fujiwara, MD, from Mount Sinai Beth Israel in New York City, and colleagues conducted a systematic review and meta-analysis to examine how adding an immune checkpoint blockade to perioperative therapy affects treatment-related adverse events. Data were included from 28 randomized controlled trials with 16,976 cancer patients.

The researchers found no significant association for addition of an immune checkpoint blockade with increased treatment-related deaths, and this finding was consistent across immune checkpoint blockade subtypes. Across 9864 patients treated with an immune checkpoint blockade, 40 fatal toxicities were identified, with pneumonitis the most common (15.0%); among 7112 patients who were not treated with an immune checkpoint blockade, 13 fatal toxicities were identified. The incidence rates of grade 3 to 4 treatment-related adverse events, adverse events leading to treatment discontinuation, and treatment-related adverse events of any grade were increased with the addition of an immune checkpoint blockade (odds ratios, 2.73, 3.67, and 2.60, respectively). Increased incidence rates of treatment-related deaths and grade 3 to 4 adverse events were seen in association with an immune checkpoint blockade vs placebo design primarily used as adjuvant therapy (odds ratios, 4.02 and 5.31, respectively), while incidence was not increased with the addition of an immune checkpoint blockade in the neoadjuvant setting.

“Our analysis points to a need for further research into risk factors and identification of appropriate biomarkers to predict both efficacy and toxicity associated with cancer immunotherapy,” Fujiwara said in a statement.

Several authors disclosed ties to the biopharmaceutical industry.

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Anlan Cao, MBBS, from Yale University in New Haven, Connecticut, and colleagues evaluated the effect of a 6-month aerobic exercise intervention on CIPN among women treated for ovarian cancer. The analysis included 134 participants in the Women’s Activity and Lifestyle Study in Connecticut (65 controls).

The researchers found that at 6 months, the self-reported CIPN score was 1.3 points lower in the exercise intervention arm (95% CI, −2.3 to −0.2) vs an increase of 0.4 points in the attention control arm (95% CI, −0.8 to 1.5). The between-group difference was −1.6 points (95% CI, −3.1 to −0.2). Among participants with CIPN symptoms at baseline, the point estimate was larger (−2.0; 95% CI, −3.6 to −0.5).

“While replication of the findings in other studies is warranted, incorporating referrals to exercise programs into standard oncology care could reduce CIPN symptoms and increase quality of life in patients with ovarian cancer,” the authors write.

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Artificial intelligence (AI) chatbots can sometimes provide accurate information about cancers, but these tools have limitations, according to a pair of studies published in JAMA Oncology.^1,2

In the first study, researchers assessed chatbots’ responses to the top Internet searches related to 5 cancers.¹ The chatbots provided information that was generally of high quality but not always actionable, and it was written at a college reading level.

In the second study, researchers found that a chatbot’s responses to queries about cancer treatments did not always align with recommendations in National Comprehensive Cancer Network (NCCN) guidelines.²

Most-Searched Queries About Cancers

Alexander Pan, of SUNY Downstate Health Sciences University in Brooklyn, New York, and colleagues evaluated chatbots’ responses to the top 5 search queries for skin, colorectal, prostate, lung, and breast cancers.¹ All queries contained the terms “cancer symptoms” and “what is [specific cancer].”

The researchers tested 4 chatbots, ChatGPT, Perplexity, Chatsonic, and Bing AI. The team used the DISCERN validation tool to assess the quality of information the chatbots provided and the Patient Education Materials Assessment Tool (PEMAT) to analyze the understandability and actionability of responses. On a scale of 1-5 (DISCERN) or 0%-100% (PEMAT), higher scores on the validation tools indicated higher-quality responses.

The quality of the cancer information provided by the chatbots was high, with a median DISCERN score of 5 (range, 2-5). However, the information was of moderate understandability. The median PEMAT score was 66.7% (range, 33.3%-90.1%), which the researchers deemed “college reading level.” Furthermore, the chatbots often failed to provide actionable responses, with a median PEMAT score of 20.0% (range, 0%-40.0%).

“These limitations suggest that AI chatbots should be used supplementarily and not as a primary source for medical information,” the researchers concluded.

ChatGPT and Cancer Treatment Recommendations

Shan Chen, of Mass General Brigham in Boston, and colleagues evaluated whether ChatGPT responded to queries about cancer treatments with recommendations that were in line with NCCN guidelines.²

Because ChatGPT’s knowledge cutoff was September 2021, the researchers measured responses against the 2021 NCCN guidelines. Responses were assessed by board-certified oncologists. The researchers used 104 queries for breast, prostate, and lung cancer. The chatbot provided at least 1 treatment recommendation for 102 of the queries (98%). All of these responses included at least 1 NCCN-concordant recommendation, but 35 (34.3%) also included at least 1 non-concordant recommendation. Additionally, 13 of 104 chatbot responses (12.5%) were “hallucinated”, that is, they were not part of any recommended treatment for the specified cancer.

“The chatbot did not purport to be a medical device and need not be held to such standards,” the researchers noted. “However, patients will likely use such technologies in their self-education, which may affect shared decision-making and the patient-clinician relationship. Developers should have some responsibility to distribute technologies that do not cause harm, and patients and clinicians need to be aware of these technologies’ limitations.”

Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original references for a full list of disclosures.

Avzivi is a vascular endothelial growth factor inhibitor indicated for the treatment of:

• Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment.
• Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen.
• Unresectable, locally advanced, recurrent or metastatic nonsquamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment.
• Recurrent glioblastoma in adults.
• Metastatic renal cell carcinoma in combination with interferon alfa.
• Persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan.
• Epithelial ovarian, fallopian tube, or primary peritoneal cancer, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than 2 prior chemotherapy regimens.

The approval was based on a comprehensive data package that included a pharmacokinetic study (ClinicalTrials.gov Identifier: NCT05865574) in healthy individuals, as well as a phase 3 comparative study (ClinicalTrials.gov Identifier: NCT03329911) in patients with advanced nonsquamous non-small cell lung cancer.

“The global phase 3 clinical trial has confirmed that Avzivi is highly similar to Avastin in terms of efficacy, safety and immunogenicity,” said professor Li Zhang, leading investigator for global phase 3 study of Avzivi. “The approval of Avzivi by the FDA will provide lung and colorectal cancer patients a new cost-effective treatment option.”

Breakthroughs in targeted therapy and immunotherapy are partly responsible for the recent decline in cancer deaths seen in the United States, according to the AACR Cancer Progress Report 2023.¹

The overall rate of cancer death in the US fell by 33% between 1991 and 2020, which translates to 3.8 million lives saved, according to the report. Death rates have decreased for lung cancer, colorectal cancer, prostate cancer, female breast cancer, and melanoma.

“These gains have really reflected a whole variety of different advances, but mostly this has been about efforts in basic science,” AACR President Philip D. Greenberg, MD, of Fred Hutchinson Cancer Research Center in Seattle, said during a presentation about the AACR report.

Dr Greenberg noted that initiatives such as the Human Genome Project and The Cancer Genome Atlas have enabled the creation of targeted therapies, which are “increasingly precise and decreasingly toxic.”

Immunotherapy breakthroughs have also reduced the toxicity of treatments, leading to improved quality of life for patients. “Precision oncology, personalized medicine; it’s about creating drugs and using them to very selectively target the disease and not injure the person,” Dr Greenberg summarized.

The AACR report highlighted several targeted therapies with unique mechanisms of action that have been approved by the US Food and Drug Administration (FDA) since the early 2000s, including gefitinib in 2003, crizotinib in 2011, and sotorasib in 2021.

All of these therapies were approved to treat lung cancer, and these approvals coincided with declining lung cancer deaths. The decrease in lung cancer deaths per year grew from 0.9% between 1995 and 2005 to nearly 5% between 2014 and 2020.

The report also highlighted more recent FDA approvals. Between August 1, 2022, and July 31, 2023, the FDA approved 14 new cancer therapies and expanded the approved use of 12 therapies to encompass new cancers. The therapies include a range of cell-signaling inhibitors, antibody-drug conjugates, bispecific antibodies, and immune checkpoint inhibitors.

“A decade ago, there was 1 single immune checkpoint inhibitor,” Dr Greenberg pointed out. “Now . . . 11 checkpoint inhibitors have now been approved by the FDA up through 2023. And rather than using it to treat the single disease that it was approved for a decade ago, we now use it to treat 20 diseases.”

Two new imaging agents — pafolacianine and flotufolastat fluorine-18 —were also approved by the FDA between August 1, 2022, and July 31, 2023.

Ongoing Challenges

“Of course, despite all this progress, there’s a whole lot of work that needs to be done,” Dr Greenberg said. “There are still, even now, structural barriers for lots of people. There’s clearly disproportionate medical care being delivered to medically underserved populations. This includes, of course, racial and ethnic minorities, but it also includes the rural populations, which is not commonly appreciated, but rural populations participate very minimally in cancer trials.”

“Similarly, although precision medicine has really improved outcomes, we need ways of expanding that so that it includes more diseases,” Dr Greenberg added. “Pancreatic cancer, for example, and glioblastoma still have horrible 5-year relative survival rates, and so we need new advances.”

To address some of these challenges, the AACR has launched a new initiative known as the AACR Cancer Centers Alliance.²  The initiative aims to encourage collaboration among US cancer centers and “accelerate the pace of discovery by providing an ongoing mechanism for transferring new knowledge, sharing resources . . ., and driving innovation that impacts cancer science, cancer care delivery, and science and health policy.”²

Dr Greenberg suggested that the future of cancer research is bright. “I really enthusiastically look forward to what can happen,” he said. “I think there’s no reason not to be optimistic. . . . We’re in this time of unparalleled opportunities.”

Disclosures: Dr Greenberg has relationships with Affini-T, Rapt Therapeutics, Elpiscience, Fibrogen, Immunoscape, Metagenomi, Earli, Catalio, and Nextech. No disclosures were provided in relation to the AACR Cancer Progress Report 2023. Some authors of the Cancer Discovery article declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the article for a full list of disclosures.

Cancer patients were more likely to die from the BA.1 and BA.2 omicron variants of SARS-CoV-2 than from wild-type SARS-CoV-2, according to research published in JAMA Oncology.^1,2

The study showed that, among US cancer patients, COVID-19 deaths were more likely during the initial omicron wave when the BA.1 and BA.2 variants were in circulation (December 2021 to February 2022) than when wild-type SARS-CoV-2 was circulating (December 2020 to February 2021).

According to data from the US Centers for Disease Control and Prevention, there were 54,692 COVID-19 deaths among patients with cancer and 1,008,510 COVID-19 deaths in the general population from March 1, 2020, through May 31, 2022.

This study included 34,350 patients with cancer and 628,156 individuals from the general population who died from COVID-19 when wild-type SARS-CoV-2 was in circulation (December 2020-February 2021), the delta variant was in circulation (July 2021-November 2021), or the BA.1 and BA.2 omicron variants were in circulation (December 2021-February 2022).

The highest number of COVID-19-related deaths among patients with cancer occurred during the 2021-2022 omicron wave. At the peak of this wave, in January 2022, there were 18% more deaths than during the peak of the wild-type period, which occurred during January 2021.

This trend was maintained when patients were stratified by age group. The number of deaths per month among patients with cancer younger than 50 years of age was 64% higher during the 2021 to 2022 omicron wave than during the wild-type wave. The number was 62% higher among patients aged 50 to 59 years, 31% higher for those aged 60 to 69 years, and 16% higher for those aged 70 to 79 years.

When the researchers looked at individual cancer types, they found that COVID-19 deaths were more likely during the 2021-2022 omicron wave for most cancer types. The exceptions were brain cancer (mortality ratio [MR], 0.77; 95% CI, 0.65-0.90), thyroid cancer (MR, 0.76; 95% CI, 0.54-0.99), and bladder cancer (MR, 0.58; 95% CI, 0.52-0.65).

Patients with lymphoma had the greatest increase in deaths from the wild-type wave to the 2021 to 2022 omicron wave, at 38% (mortality ratio [MR], 1.38; 95% CI, 1.31-1.45).

In the general population, the highest number of COVID-19 deaths per month occurred when wild-type SARS-CoV-2 was prevalent. At the peak of the initial omicron wave in January 2022, there were 21% fewer deaths in the general US population than at the peak of the wild-type period in January 2021 (MR, 0.69; 95% CI, 0.69-0.70).

“[W]hile the general US population experienced a large reduction in COVID-19 mortality during the winter Omicron period, patients with cancer experienced the highest COVID-19 mortality during the winter Omicron period, likely due to increased SARS-CoV-2 exposure during this period combined with the reduced effectiveness of COVID-19 vaccines and increased risk of COVID-19 mortality in this population,” the researchers wrote. “With future COVID-19 waves imminent, strategies to protect those at highest risk should remain a high priority, even during future pandemic waves with less virulent SARS-CoV-2 variants.”

Disclosures: One of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

References

1. Potter AL, Vaddaraju V, Venkateswaran S, et al. Deaths due to COVID-19 in patients with cancer during different waves of the pandemic in the US. JAMA Oncol. Published online August 31, 2023. doi: 10.1001/jamaoncol.2023.3066

2. SARS-CoV-2 sequences by variant, United States, Jan 3, 2022. Our World in Data. Updated August 22, 2023. Accessed September 1, 2023.

Chemotherapy-Induced Nausea and Vomiting Prophylaxis

The cisplatin shortage that has affected cancer centers and patients across the US is nearly resolved, according to a statement from the Biden Administration.¹

The White House reported last week that the cisplatin supply has been restored to almost 100% of pre-shortage levels.

According to the US Food and Drug Administration’s (FDA) drug shortage database, 3 companies had cisplatin available on allocation as of September 18.² Additional supplies of cisplatin are expected to be released this month and next month.

The shortage of cisplatin has occurred alongside prolonged shortages of several other cancer drugs, including methotrexate and carboplatin.³ In June, the National Comprehensive Cancer Network (NCCN) published survey results reporting that cisplatin was in short supply at 70% of included cancer centers, and carboplatin was in short supply at 93%.⁴

The FDA has worked to alleviate these shortages over the past several months.¹ In June, the FDA announced that it would work with Chinese drugmaker Qilu Pharmaceutical and Canadian pharmaceutical company Apotex to temporarily import cisplatin.⁵ According to the FDA, distribution of this product has been completed.²

The FDA also worked with various drug manufacturers to increase production of cisplatin, carboplatin, and methotrexate.¹ According to the FDA database, several companies have methotrexate and carboplatin available now, and additional supplies of both drugs are expected this month and next month.²

“The Administration will continue to work through the FDA, the Department of Health and Human Services, and other agencies to address and prevent drug shortages and mitigate impacts to people facing a cancer diagnosis,” the White House said in its statement.¹

Phase 3 trial results support the use of niraparib maintenance as standard care in patients with advanced ovarian cancer, according to researchers.

The researchers found that niraparib maintenance improved progression-free survival (PFS), regardless of biomarker status or postoperative residual disease. These results, from the phase 3 PRIME trial, were published in JAMA Oncology. 

The trial (ClinicalTrials.gov Identifier: NCT03709316) included 384 patients with newly diagnosed stage III/IV ovarian cancer. At baseline, the patients’ median age was 54 (range, 32-77) years, 71.9% had stage IV disease, and 32.6% had germline BRCA variants.

Roughly half of patients (46.9%) received neoadjuvant chemotherapy. All patients underwent primary or interval debulking surgery and achieved a response after 6 to 9 cycles of platinum-based chemotherapy. Thirteen percent of patients had suboptimal debulking surgery, and 18.0% had a partial response to chemotherapy.

The patients were randomly assigned to niraparib (n=255) or placebo (n=129) maintenance with an individualized starting dose. The starting dose of niraparib was 200mg per day for the 274 patients who weighed less than 77kg and/or had a platelet count below 150 x 10³/μL at baseline. The remaining 8 patients had a niraparib starting dose of 300mg per day.

The median duration of maintenance was 19.3 months in the niraparib arm and 10.2 months in the placebo arm. The compliance rate was at least 80% in 93.3% of patients in the niraparib arm and 98.4% of patients in the placebo arm.

At a median follow-up of 27.5 months, niraparib improved PFS in the intent-to-treat population. The median PFS was 24.8 months in the niraparib arm and 8.3 months in the placebo arm (hazard ratio [HR], 0.45; 95% CI, 0.34-0.60; P <.001).

Niraparib also improved PFS across subgroups, including in patients:

• With germline BRCA variants (HR, 0.40; 95% CI, 0.23-0.68);
• Without germline BRCA variants (HR, 0.48; 95% CI, 0.34-0.67);
• With homologous recombination-proficient disease (HR, 0.41; 95% CI, 0.22-0.75);
• With homologous recombination-indeterminate disease (HR, 0.36; 95% CI, 0.15-0.86);
• With optimal debulking surgery (HR, 0.44; 95% CI, 0.32-0.61);
• With suboptimal debulking surgery (HR, 0.27; 95% CI, 0.10-0.72).

In the intent-to-treat population, niraparib improved the median time to first subsequent therapy (TFST). The median TFST was 29.2 months in the niraparib arm and 11.9 months in the placebo arm (HR, 0.45; 95% CI, 0.34-0.59; P < .001).

Overall survival data were not mature. However, the 24-month overall survival rate was 87.3% in the niraparib arm and 82.7% in the placebo arm.

Grade 3 or higher treatment-emergent adverse events (TEAEs) occurred in 54.5% of patients in the niraparib arm and 17.8% of those in the placebo arm. Serious TEAEs occurred in 18.8% and 8.5%, respectively.

The most common grade 3 or higher TEAEs in the niraparib arm were anemia (18.0%), decreased neutrophil count (17.3%), decreased platelet count (14.1%), and decreased white blood cell count (6.7%). One patient in the niraparib arm developed myelodysplastic syndrome, and 1 developed acute myeloid leukemia, which was fatal.

“The results of this randomized clinical trial support niraparib monotherapy as a standard of care after first-line platinum-based chemotherapy in a broad patient population with advanced ovarian cancer,” the researchers wrote.

Disclosures: This research was supported by Zai Lab Co, Ltd. Some study authors declared affiliations with Zai Lab. Please see the original reference for a full list of disclosures.

This is despite the fact that cancer survivors are more likely to be vaccinated against COVID-19 and just as likely as the general population to be infected with SARS-CoV-2. These findings were published in the Journal of the National Cancer Institute.

For this study, researchers evaluated data from the National Health Interview Survey in 2021 and 2022. The cohort from 2021 included 3428 cancer survivors and 26,023 control individuals without a cancer history. The cohort from 2022 included 3218 cancer survivors and 24,393 control individuals.

The cancer survivors were more likely than control individuals to have received 2 or more COVID-19 vaccines in 2021 (66.6% and 62.3%, respectively; P =.003) and 2022 (77.0% and 72.4%, respectively; P <.001).

However, cancer survivors were just as likely as control individuals to report having COVID-19 in 2021 (14.1% and 14.2%, respectively; P =.93) and 2022 (39.9% and 39.3%, respectively; P =.55).

Cancer survivors were more likely than control individuals to report moderate to severe COVID-19 symptoms in 2021 (62.5% and 54.2%, respectively; P =.02). In 2022, there was a trend toward more moderate and severe COVID-19 among cancer survivors, but the difference between cancer survivors and control individuals was not statistically significant (54.5% and 51.3%, respectively; P =.13).

However, the data from 2022 showed that cancer survivors were more likely than control individuals to have symptoms of long COVID (20.6% and 17.3%, respectively; P =.04). There were no data on long COVID from 2021.

“With the continuing high infectious rate and seasonal resurgences of COVID-19 infections and ongoing recommendations for vaccination, especially for vulnerable populations, monitoring the impact of COVID-19 infection and the effectiveness of prevention and control strategies continue to be a public health priority,” the researchers wrote. “Our findings suggest the need for tailored efforts to prevent and control COVID-19 infection for cancer survivors.”

Rachel L. Winer, PhD, MPH, from the University of Washington in Seattle, and colleagues examined the effectiveness of direct-mail and opt-in approaches for offering HPV self-sampling kits to individuals by cervical cancer screening history (due for screening, overdue, or unknown) in a randomized clinical trial involving women aged 30 to 64 years. Individuals stratified as due were randomly assigned to receive usual care (patient reminders and clinician electronic health record alerts), education (usual care plus educational materials), direct mail (usual care plus educational materials plus a mailed self-sampling kit), or opt-in (usual care plus educational materials and the option to request a kit; 3671; 3960; 1482; and 3956 participants, respectively). Individuals who were overdue were randomly assigned to usual care, education, or direct mail (5488; 1408; and 1415 participants, respectively). Individuals with unknown screening history were randomly assigned to usual care, education, or opt-in (2983; 3486; and 3506, respectively).

The researchers found that among those due for screening, screening completion was 14.1 and 3.5% higher in the direct-mail and opt-in groups, respectively, compared with receiving education alone. Screening completion was 16.9% higher in the direct-mail versus education-alone group among overdue individuals. Screening was 2.2% higher for the opt-in vs the education-alone group among those with unknown history.

“To increase screening adherence, systems implementing HPV self-sampling should prioritize direct-mail outreach for individuals who are due and overdue for screening,” the authors write.

Two authors disclosed ties to UnitedHealthcare.

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The Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application for dostarlimab in combination with chemotherapy for the treatment of adults with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer.

Dostarlimab is a programmed death receptor-1 (PD-1)-blocking antibody. The sBLA was supported by data from Part 1 of the phase 3 RUBY trial (ClinicalTrials.gov Identifier: NCT03981796), which included women with recurrent or primary advanced (stage III or IV) endometrial cancer. Study participants were randomly assigned to receive dostarlimab plus carboplatin-paclitaxel, followed by dostarlimab or carboplatin-paclitaxel plus placebo, followed by placebo. The primary endpoints were progression free survival (PFS) and overall survival (OS).

Results showed that in the dMMR/MSI-H population (n=118), treatment with dostarlimab plus carboplatin-paclitaxel reduced the risk of disease progression by 72% compared with placebo (estimated PFS at 24 months: 61.4% vs 15.7% for placebo; hazard ratio [HR], 0.28; 95% CI, 0.16-0.50; P <.001).  In the overall population (n=494), PFS was 36.1% in dostarlimab arm and 18.1% in the placebo arm (HR, 0.64; 95% CI, 0.51-0.80; P <.001). At 24 months, a clinically meaningful OS trend was observed in patients receiving dostarlimab plus chemotherapy followed by dostarlimab.

“We are excited about this initial filing for this potential new indication for dostarlimab in the patient population that demonstrated the strongest treatment effect in the phase 3 RUBY trial,” said Hesham Abdullah, Senior Vice President, Global Head of Oncology Development, GSK. “Long-term outcomes for patients with primary advanced or recurrent endometrial cancer remain poor, and there is an urgent need to evolve the current standard of care, which is platinum-based chemotherapy. We look forward to working with the FDA and other health authorities as they review this application.”

A regulatory decision is expected on September 23, 2023.

Dostarlimab is currently marketed under the brand name Jemperli for adult patients with dMMR recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation. It is also approved for patients with dMMR recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options.