US FDA expands Jemperli (dostarlimab-gxly) plus chemotherapy approval to all adult patients with primary advanced or recurrent endometrial cancer as the first and only immuno-oncology-based treatment to show an overall survival benefit

Rhea-AI Summary

GSK announced that the US FDA has expanded the approval of Jemperli (dostarlimab-gxly) in combination with chemotherapy for treating adult patients with primary advanced or recurrent endometrial cancer. This approval now includes MMRp/MSS tumors, representing 70-75% of endometrial cancer cases. The decision is based on the RUBY phase III trial results, which showed a 31% reduction in the risk of death compared to chemotherapy alone. At the 2.5-year mark, 61% of patients in the Jemperli plus chemotherapy group were alive compared to 49% in the chemotherapy-only group. The median overall survival improved by 16.4 months with Jemperli plus chemotherapy. This makes Jemperli the first and only immuno-oncology-based treatment to demonstrate an overall survival benefit in this patient population.

Positive

• Expanded FDA approval for Jemperli in combination with chemotherapy for endometrial cancer
• 31% reduction in risk of death compared to chemotherapy alone
• 16.4-month improvement in median overall survival
• First immuno-oncology treatment to show overall survival benefit in this patient population
• Approval includes MMRp/MSS tumors, representing 70-75% of endometrial cancer cases

Negative

• None.

Oncology Expert

The FDA's expanded approval of Jemperli (dostarlimab-gxly) in combination with chemotherapy for all adult patients with primary advanced or recurrent endometrial cancer is a significant breakthrough in oncology. This approval is particularly impactful as it now includes patients with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumors, who represent 70-75% of endometrial cancer cases.

The RUBY phase III trial results are remarkable, showing a 31% reduction in the risk of death compared to chemotherapy alone. The 16.4-month improvement in median overall survival is substantial in the context of endometrial cancer treatment. At the 2.5-year mark, 61% of patients in the Jemperli plus chemotherapy group were alive, compared to 49% in the chemotherapy-only group.

This approval is groundbreaking because:

• It's the first immuno-oncology-based treatment to demonstrate an overall survival benefit in this patient population.
• It addresses a significant unmet need for patients with MMRp/MSS tumors, who previously had treatment options.
• The safety profile is consistent with known profiles of individual agents, which is important for patient tolerability and quality of life during treatment.

As an oncologist, I see this as a potential new standard of care for advanced or recurrent endometrial cancer, regardless of biomarker status. The extension of survival by over a year is a meaningful improvement that could significantly impact patients' lives and their families.

Medical Research Analyst

The expanded approval of Jemperli (dostarlimab-gxly) in combination with chemotherapy for endometrial cancer patients is a testament to the power of innovative clinical trial design and the potential of immunotherapy in gynecologic cancers. The RUBY phase III trial's dual primary endpoint approach, focusing on both progression-free survival (PFS) and overall survival (OS), provides robust evidence for the efficacy of this combination therapy.

Key points to consider:

• The trial's median follow-up of over three years lends credibility to the long-term efficacy and safety data.
• The statistically significant OS benefit (HR: 0.69; 95% CI: 0.54–0.89) is a gold standard outcome in oncology trials.
• The inclusion of MMRp/MSS tumors in this approval is crucial, as these patients typically have a poorer prognosis and fewer treatment options.

From a research perspective, this approval underscores the importance of biomarker-agnostic approaches in certain cancer types. While precision medicine has been a focus in oncology, this study demonstrates that some immunotherapy combinations can benefit a broader patient population.

The safety profile, being consistent with known profiles of individual agents, suggests that the combination doesn't introduce unexpected toxicities. This is important for patient quality of life and treatment adherence. However, ongoing post-marketing surveillance will be important to identify any rare or long-term adverse events.

This approval sets a new benchmark for future clinical trials in endometrial cancer and potentially other gynecologic malignancies, emphasizing the importance of overall survival as a primary endpoint in addition to progression-free survival.

Financial Analyst

The FDA's expanded approval of Jemperli (dostarlimab-gxly) in combination with chemotherapy for all adult patients with primary advanced or recurrent endometrial cancer is a significant milestone for GSK plc (LSE/NYSE: GSK). This development has several financial implications:

• Market Expansion: The inclusion of MMRp/MSS tumors, representing 70-75% of endometrial cancer cases, substantially enlarges the potential patient population for Jemperli. This could lead to a significant increase in revenue from this drug.
• Competitive Advantage: Being the first and only immuno-oncology-based treatment to show an overall survival benefit in this indication gives GSK a strong market position. This could translate into premium pricing and potentially higher profit margins.
• Research and Development Validation: The success of the RUBY phase III trial validates GSK's R&D strategy in oncology, potentially boosting investor confidence in the company's pipeline.
• Regulatory Success: The Priority Review and ahead-of-schedule approval demonstrate GSK's ability to navigate regulatory pathways effectively, which is valuable for future drug approvals.

Financially, this approval could be a significant growth driver for GSK's oncology portfolio. In Q3 2023, Jemperli sales were £47 million, up 62% at AER, 67% CER. With this expanded indication, we could see a substantial acceleration in sales growth.

However, investors should also consider:

• The competitive landscape in endometrial cancer treatment
• Potential pricing pressures in the oncology market
• The need for continued investment in marketing and post-approval studies

Overall, this approval strengthens GSK's position in the lucrative oncology market and could contribute significantly to the company's future revenue growth and profitability.

• Jemperli approval now includes MMRp/MSS tumors, which represent majority of endometrial cancer cases
• Jemperli plus chemotherapy demonstrated a statistically significant and clinically meaningful 31% reduction in risk of death versus chemotherapy alone

PHILADELPHIA--(BUSINESS WIRE)-- GSK plc (LSE/NYSE: GSK) today announced the US Food and Drug Administration (FDA) has approved Jemperli (dostarlimab-gxly) in combination with carboplatin and paclitaxel (chemotherapy) followed by Jemperli as a single agent for the treatment of adult patients with primary advanced or recurrent endometrial cancer. This approval broadens the previous indication for Jemperli plus chemotherapy to include patients with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumors who represent 70-75% of patients diagnosed with endometrial cancer and who have limited treatment options. The supplemental Biologics License Application (sBLA) supporting this expanded indication received Priority Review and was approved ahead of the Prescription Drug User Fee Act action date.

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: “Jemperli plus chemotherapy is the first and only immuno-oncology regimen to show significant and meaningful improvement in overall survival for adult patients with primary advanced or recurrent endometrial cancer regardless of biomarker status. We are thrilled this option is now available for more patients in the US, including the 70-75% with MMRp/MSS tumors where treatment options have been limited.”

Today’s expanded approval is based on results from dual primary endpoints of investigator-assessed progression-free survival (PFS) and overall survival (OS) from Part 1 of the RUBY phase III trial. RUBY Part 1 is the only clinical trial in this setting to show a statistically significant OS benefit in the full population of patients with primary advanced or recurrent endometrial cancer, demonstrating a 31% reduction in risk of death (HR: 0.69; 95% CI: 0.54–0.89) compared to chemotherapy alone.

At the 2.5-year landmark, 61% (95% CI: 54-67) of patients in the Jemperli plus chemotherapy group compared to 49% (95% CI: 43-55) in the chemotherapy group were alive. In addition, a 16.4-month improvement in median OS was observed with Jemperli plus chemotherapy versus chemotherapy alone (44.6 months [95% CI: 32.6–NR] vs. 28.2 months [95% CI: 22.1–35.6], respectively). The median duration of follow-up was more than three years.¹ The safety and tolerability analysis from RUBY Part 1 showed a safety profile for Jemperli and carboplatin-paclitaxel that was generally consistent with the known safety profiles of the individual agents. The most common treatment-emergent adverse events (≥ 20%) in patients receiving Jemperli plus chemotherapy were nausea, alopecia, fatigue, peripheral neuropathy, anemia, arthralgia, constipation, diarrhea, myalgia, rash, hypomagnesemia, decreased appetite, peripheral sensory neuropathy and vomiting.

Matthew Powell, MD, Chief, Division of Gynecologic Oncology, Washington University School of Medicine, and US principal investigator of the RUBY trial said: “The initial approval of Jemperli plus chemotherapy was practice-changing for patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer and today’s expanded approval will offer even more patients the opportunity for improved outcomes. This is the only immuno-oncology treatment regimen that has shown a statistically significant overall survival benefit for the full patient population, which is a meaningful step forward in treating this challenging cancer.”

Adrienne Moore, Survivor, Founding Member and President of Endometrial Cancer Action Network for African-Americans (ECANA) said: “With this expanded approval for Jemperli plus chemotherapy, GSK is bringing a much-needed new treatment regimen to the endometrial cancer community that may help patients with primary advanced or recurrent endometrial cancer live longer, providing hope to patients and their families. Survivors and advocates should be excited by today’s news and especially delighted that this approval means that more patients in the US who are diagnosed with endometrial cancer will have a new treatment option.”

About endometrial cancer
Endometrial cancer is found in the inner lining of the uterus, known as the endometrium. Endometrial cancer is the most common gynecologic cancer in developed countries,² with an estimated 1.6 million people living with active disease at any stage and 417,000 new cases reported each year worldwide.³ Incidence rates are expected to rise by approximately 40% between 2020 and 2040.⁴ Approximately 15-20% of patients with endometrial cancer will be diagnosed with advanced disease at the time of diagnosis.⁵ Among patients with primary advanced or recurrent endometrial cancer, approximately 70-75% have MMRp/MSS tumors.⁶

About RUBY
RUBY is a two-part global, randomized, double-blind, multi-center phase III trial of patients with primary advanced or recurrent endometrial cancer. Part 1 is evaluating dostarlimab-gxly plus carboplatin-paclitaxel followed by dostarlimab-gxly versus carboplatin-paclitaxel plus placebo followed by placebo. Part 2 is evaluating dostarlimab-gxly plus carboplatin-paclitaxel followed by dostarlimab-gxly plus niraparib versus placebo plus carboplatin-paclitaxel followed by placebo.

In Part 1, the dual-primary endpoints are investigator-assessed PFS based on the Response Evaluation Criteria in Solid Tumors v1.1 and OS. The statistical analysis plan included pre-specified analyses of PFS in the mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) and overall populations and OS in the overall population. Pre-specified exploratory analyses of PFS and OS in the MMRp/MSS population and OS in the dMMR/MSI-H populations were also performed. RUBY Part 1 included a broad population, including histologies often excluded from clinical trials and had approximately 10% of patients with carcinosarcoma and 20% with serous carcinoma.

In Part 2, the primary endpoint is investigator-assessed PFS in the overall population, followed by PFS in the MMRp/MSS population, and OS in the overall population is a key secondary endpoint. Additional secondary endpoints in Part 1 and Part 2 include PFS per blinded independent central review, PFS2, overall response rate, duration of response, disease control rate, patient-reported outcomes, and safety and tolerability.

RUBY is part of an international collaboration between the European Network of Gynaecological Oncological Trial groups (ENGOT), a research network of the European Society of Gynaecological Oncology (ESGO) that consists of 22 trial groups from 31 European countries that perform cooperative clinical trials, and the GOG Foundation, a non-profit organization dedicated to transforming the standard of care in gynecologic oncology.

About Jemperli (dostarlimab-gxly)
Jemperli, a programmed death receptor-1 (PD-1)-blocking antibody, is the backbone of GSK’s ongoing immuno-oncology-based research and development program. A robust clinical trial program includes studies of Jemperli alone and in combination with other therapies in gynecologic, colorectal and lung cancers, as well as where there are opportunities for transformational outcomes.

Jemperli was discovered by AnaptysBio, Inc. and licensed to TESARO, Inc., under a collaboration and exclusive license agreement signed in March 2014. Under this agreement, GSK is responsible for the ongoing research, development, commercialization, and manufacturing of Jemperli and cobolimab (GSK4069889), a TIM-3 antagonist.

Indications and Important Safety Information for JEMPERLI (dostarlimab-gxly)

• JEMPERLI, in combination with carboplatin and paclitaxel, followed by JEMPERLI as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial cancer (EC).
• JEMPERLI, as a single agent, is indicated for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced:
  • EC, as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen in any setting and are not candidates for curative surgery or radiation, or
  • 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. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Important Safety Information

Severe and Fatal Immune-Mediated Adverse Reactions

• Immune-mediated adverse reactions, which can be severe or fatal, can occur in any organ system or tissue and can occur at any time during or after treatment with a PD-1/PD-L1–blocking antibody, including JEMPERLI.
• Monitor closely for signs and symptoms of immune-mediated adverse reactions. Evaluate liver enzymes, creatinine, and thyroid function tests at baseline and periodically during treatment. For suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.
• Based on the severity of the adverse reaction, withhold or permanently discontinue JEMPERLI. In general, if JEMPERLI requires interruption or discontinuation, administer systemic corticosteroids (1 to 2 mg/kg/day prednisone or equivalent) until improvement to ≤Grade 1. Upon improvement to ≤Grade 1, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reaction is not controlled with corticosteroids.

Immune-Mediated Pneumonitis

• JEMPERLI can cause immune-mediated pneumonitis, which can be fatal. In patients treated with other PD-1/PD-L1–blocking antibodies, the incidence of pneumonitis is higher in patients who have received prior thoracic radiation. Pneumonitis occurred in 2.3% (14/605) of patients, including Grade 2 (1.3%), Grade 3 (0.8%), and Grade 4 (0.2%) pneumonitis.

Immune-Mediated Colitis

• Colitis occurred in 1.3% (8/605) of patients, including Grade 2 (0.7%) and Grade 3 (0.7%) adverse reactions. Cytomegalovirus infection/reactivation have occurred in patients with corticosteroid-refractory immune-mediated colitis. In such cases, consider repeating infectious workup to exclude alternative etiologies.

Immune-Mediated Hepatitis

• JEMPERLI can cause immune-mediated hepatitis, which can be fatal. Grade 3 hepatitis occurred in 0.5% (3/605) of patients.

Immune-Mediated Endocrinopathies

• Adrenal Insufficiency
  • Adrenal insufficiency occurred in 1.2% (7/605) of patients, including Grade 2 (0.5%) and Grade 3 (0.7%). For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment per institutional guidelines, including hormone replacement as clinically indicated. Withhold or permanently discontinue JEMPERLI depending on severity.
• Hypophysitis
  • JEMPERLI can cause immune-mediated hypophysitis. Grade 3 hypophysitis occurred in 0.4% (1/241) of patients receiving JEMPERLI in combination with carboplatin and paclitaxel. Grade 2 hypophysitis occurred in 0.2% (1/605) of patients receiving JEMPERLI as a single agent. Initiate hormone replacement as clinically indicated. Withhold or permanently discontinue JEMPERLI depending on severity.
• Thyroid Disorders
  • Grade 2 thyroiditis occurred in 0.5% (3/605) of patients. Grade 2 hypothyroidism occurred in 12% (30/241) of patients receiving JEMPERLI in combination with carboplatin and paclitaxel. Grade 2 hypothyroidism occurred in 8% (46/605) of patients receiving JEMPERLI as a single agent. Hyperthyroidism occurred in 3.3% (8/241) of patients receiving JEMPERLI in combination with carboplatin and paclitaxel, including Grade 2 (2.9%) and Grade 3 (0.4%). Hyperthyroidism occurred in 2.3% (14/605) of patients receiving JEMPERLI as a single agent, including Grade 2 (2.1%) and Grade 3 (0.2%). Initiate thyroid hormone replacement or medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue JEMPERLI depending on severity.
• Type 1 Diabetes Mellitus, Which Can Present with Diabetic Ketoacidosis
  • JEMPERLI can cause type 1 diabetes mellitus, which can present with diabetic ketoacidosis. Grade 3 type 1 diabetes mellitus occurred in 0.4% (1/241) of patients receiving JEMPERLI in combination with carboplatin and paclitaxel. Grade 3 type 1 diabetes mellitus occurred in 0.2% (1/605) of patients receiving JEMPERLI as a single agent. Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold or permanently discontinue JEMPERLI depending on severity.

Immune-Mediated Nephritis with Renal Dysfunction

• JEMPERLI can cause immune-mediated nephritis, which can be fatal. Grade 2 nephritis, including tubulointerstitial nephritis, occurred in 0.5% (3/605) of patients.

Immune-Mediated Dermatologic Adverse Reactions

• JEMPERLI can cause immune-mediated rash or dermatitis. Bullous and exfoliative dermatitis, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS), have occurred with PD-1/PD-L1–blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-bullous/exfoliative rashes. Withhold or permanently discontinue JEMPERLI depending on severity.

Other Immune-Mediated Adverse Reactions

• The following clinically significant immune-mediated adverse reactions occurred in <1% of the 605 patients treated with JEMPERLI or were reported with the use of other PD-1/PD-L1–blocking antibodies. Severe or fatal cases have been reported for some of these adverse reactions.
  • Nervous System: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis, Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy
  • Cardiac/Vascular: Myocarditis, pericarditis, vasculitis
  • Ocular: Uveitis, iritis, other ocular inflammatory toxicities. Some cases can be associated with retinal detachment. Various grades of visual impairment to include blindness can occur
  • Gastrointestinal: Pancreatitis, including increases in serum amylase and lipase levels, gastritis, duodenitis
  • Musculoskeletal and Connective Tissue: Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatica
  • Endocrine: Hypoparathyroidism
  • Other (Hematologic/Immune): Autoimmune hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection, other transplant (including corneal graft) rejection

Infusion-Related Reactions

• Severe or life-threatening infusion-related reactions have been reported with PD-1/PD-L1–blocking antibodies. Severe infusion-related reactions (Grade 3) occurred in 0.2% (1/605) of patients receiving JEMPERLI. Monitor patients for signs and symptoms of infusion-related reactions. Interrupt or slow the rate of infusion or permanently discontinue JEMPERLI based on severity of reaction.

Complications of Allogeneic HSCT

• Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after treatment with a PD-1/PD-L1–blocking antibody, which may occur despite intervening therapy. Monitor patients closely for transplant-related complications and intervene promptly.

Embryo-Fetal Toxicity and Lactation

• Based on its mechanism of action, JEMPERLI can cause fetal harm. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with JEMPERLI and for 4 months after their last dose. Because of the potential for serious adverse reactions from JEMPERLI in a breastfed child, advise women not to breastfeed during treatment with JEMPERLI and for 4 months after their last dose.

Common Adverse Reactions

The most common adverse reactions (≥20%), including laboratory abnormalities, in patients with EC who received JEMPERLI in combination with carboplatin and paclitaxel were decreased hemoglobin, increased creatinine, peripheral neuropathy, decreased white blood cell count, fatigue, nausea, alopecia, decreased platelets, increased glucose, decreased lymphocytes, decreased magnesium, decreased neutrophils, increased AST, arthralgia, rash, constipation, diarrhea, increased ALT, decreased potassium, decreased albumin, decreased sodium, increased alkaline phosphatase, abdominal pain, dyspnea, decreased appetite, increased amylase, decreased phosphate, urinary tract infection, and vomiting.

The most common adverse reactions (≥20%) in patients with dMMR EC who received JEMPERLI as a single agent were fatigue/asthenia, anemia, nausea, diarrhea, constipation, vomiting, and rash. The most common Grade 3 or 4 laboratory abnormalities (>2%) were decreased lymphocytes, decreased sodium, increased alanine aminotransferase, increased creatinine, decreased neutrophils, decreased albumin, and increased alkaline phosphatase.

The most common adverse reactions (≥20%) in patients with dMMR solid tumors who received JEMPERLI as a single agent were fatigue/asthenia, anemia, diarrhea, and nausea. The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased lymphocytes, decreased sodium, increased alkaline phosphatase, and decreased albumin.

Please see the full US Prescribing Information for JEMPERLI, including Medication Guide.

GSK in oncology
Oncology is an emerging therapeutic area for GSK where we are committed to maximizing patient survival with a current focus on hematologic malignancies, gynecologic cancers and other solid tumors through breakthroughs in immuno-oncology and tumor-cell targeting therapies.

About GSK
GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at us.gsk.com.

Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D “Risk factors” in GSK’s Annual Report on Form 20-F for 2023, and GSK’s Q2 Results for 2024.

Registered in England & Wales:
No. 3888792

Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS

References

___________________________________

¹ Powell MA, Bjørge L, Willmott L, et al. Overall survival in patients with endometrial cancer treated with dostarlimab plus carboplatin-paclitaxel in the randomized ENGOT-EN6/GOG-3031/RUBY trial, Annals of Oncology.2024. doi: https:// doi.org/10.1016/j.annonc.2024.05.546.
² Faizan U, Muppidi V. Uterine Cancer. [Updated 2022 Sep 5]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan. Available at: www.ncbi.nlm.nih.gov/books/NBK562313/.
³ Sung H, Ferlay J, Siegel R, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021;71(3):209-249. doi:10.3322/caac.21660
⁴ International Research on Cancer. Global Cancer Observatory. Cancer Tomorrow. Gco.iarc.fr/tomorrow/en/dataviz/. Accessed 12 Jun 2024.
⁵ CMP: CancerMPact Patient Metrics Mar-2023, Cerner Enviza. Available at www.cancermpact.com. Accessed 12 Jun 2024.
⁶ Based on CMP:CancerMPact [Patient Metrics], Cerner Enviza. Available from www.cancermpact.com. Accessed 12 Jun 2024.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240726127513/en/

GSK inquiries

Media:

Tim Foley +44 (0) 20 8047 5502 (London)

Dan Smith +44 (0) 20 8047 5502 (London)

Kathleen Quinn +1 202 603 5003 (Washington DC)

Lyndsay Meyer +1 202 302 4595 (Washington DC)

Investor Relations:

Nick Stone +44 (0) 7717 618834 (London)

James Dodwell +44 (0) 20 8047 2406 (London)

Mick Readey +44 (0) 7990 339653 (London)

Josh Williams +44 (0) 7385 415719 (London)

Camilla Campbell +44 (0) 7803 050238 (London)

Steph Mountifield +44 (0) 7796 707505 (London)

Jeff McLaughlin +1 215 751 7002 (Philadelphia)

Frannie DeFranco +1 215 751 4855 (Philadelphia)

Source: GSK plc

FAQ

What is the new FDA approval for GSK's Jemperli (dostarlimab-gxly)?

The FDA has expanded the approval of Jemperli in combination with chemotherapy for treating adult patients with primary advanced or recurrent endometrial cancer, now including MMRp/MSS tumors.

What were the key results from the RUBY phase III trial for GSK's Jemperli?

The RUBY trial showed a 31% reduction in the risk of death compared to chemotherapy alone, with 61% of patients in the Jemperli plus chemotherapy group alive at 2.5 years compared to 49% in the chemotherapy-only group.

How much did Jemperli improve overall survival in endometrial cancer patients?

Jemperli plus chemotherapy improved median overall survival by 16.4 months compared to chemotherapy alone in patients with primary advanced or recurrent endometrial cancer.

What percentage of endometrial cancer cases does the new GSK Jemperli approval cover?

The expanded approval for Jemperli now includes MMRp/MSS tumors, which represent 70-75% of patients diagnosed with endometrial cancer.

What makes GSK's Jemperli unique in the treatment of endometrial cancer?

Jemperli is the first and only immuno-oncology-based treatment to demonstrate a statistically significant overall survival benefit in the full population of patients with primary advanced or recurrent endometrial cancer.