On March 27, 2023 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, reported that GSK has shared interim results from Part 1 of the RUBY/ENGOT-EN6/GOG3031/NSGO phase 3 trial investigating Jemperli (dostarlimab-gxly) plus standard-of-care chemotherapy (carboplatin-paclitaxel) followed by dostarlimab-gxly alone compared to chemotherapy plus placebo followed by placebo in adult patients with primary advanced or recurrent endometrial cancer (Press release, AnaptysBio, MAR 28, 2023, View Source [SID1234629368]). These data from GSK’s RUBY clinical trial are being shared in a European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Plenary, presented at the Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer (25-28 March) in Tampa, Florida and published simultaneously in The New England Journal of Medicine.
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"We continue to be encouraged in the differentiated outcomes delivered by immuno-oncology antibodies discovered at AnaptysBio as GSK advances their development to treat multiple advanced solid tumors. The positive results from the RUBY trial represent a potential breakthrough for patients with primary advanced or recurrent endometrial cancer," said Daniel Faga, interim president and chief executive officer of AnaptysBio. "There is a potential significant royalty opportunity over time to AnaptysBio from Jemperli if this indication is approved, as well as from GSK’s ongoing Phase 3 trials, including of dostarlimab in first line ovarian cancer and, in combination with cobolimab, a TIM-3 antagonist, in second line NSCLC."
For specific details on the results of Part 1 of the RUBY trial, please reference the GSK stock-exchange announcement here. The safety and tolerability profile of dostarlimab-gxly in combination with carboplatin/paclitaxel in the RUBY phase 3 trial was generally consistent with the known safety profiles of the individual agents.
GSK stated in its press release that its "ambition is for dostarlimab to become the backbone of the Company’s ongoing immuno-oncology-based research and development program when used alone and in combination with standard of care and future novel cancer therapies, particularly for patients who currently have limited treatment options. Dostarlimab is being investigated in registrational enabling studies as monotherapy and as part of combination regimens, including in patients with recurrent or primary advanced endometrial cancer, patients with Stage III or IV non-mucinous epithelial ovarian cancer, and patients with other advanced solid tumors or metastatic cancers."
GSK also has advanced, in Q3 2022, both arms of the COSTAR Lung clinical trial to Phase 3, testing both doublet and triplet combinations of dostarlimab-gxly plus chemotherapy, and cobolimab (TIM-3 antagonist) plus dostarlimab-gxly plus chemotherapy in advanced non-small cell lung cancer.
Jemperli was discovered by AnaptysBio and licensed to TESARO, Inc., now a part of the GSK group of companies, under a Collaboration and Exclusive License Agreement signed in March 2014. GSK is responsible for the ongoing development and commercialization of Jemperli. AnaptysBio is entitled to receive milestones and tiered royalties of 8% for annual net sales of Jemperli below $1 billion and 12% up to 25% of annual net sales above $1 billion. In 2021, AnaptysBio monetized with Sagard Healthcare Royalty Partners certain commercial milestones and royalties for annual net sales of Jemperli below $1 billion up to a certain amount of receivables before such receivables revert back to AnaptysBio.
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 globally, with approximately 417,000 new cases reported each year worldwide[i], and incidence rates are expected to rise by almost 40% by 2040.[ii][iii] Approximately 15-20% of patients with endometrial cancer will be diagnosed with advanced disease at the time of diagnosis.[iv]
About RUBY
RUBY is a two-part global, randomized, double-blind, multicenter phase 3 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. The primary endpoints in Part 1 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 dMMR/MSI-H and ITT populations and OS in the overall population. Pre-specified exploratory analyses of PFS in the MMRp/MSS population and OS in the dMMR/MSI-H populations were also performed. Part 1 RUBY 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. Secondary endpoints in Part 1 and Part 2 include PFS per blinded independent central review, overall response rate, duration of response, disease control rate, patient-reported outcomes, and safety and tolerability.
About Jemperli (dostarlimab-gxly)
Jemperli is a programmed death receptor-1 (PD-1)-blocking antibody that binds to the PD-1 receptor and blocks its interaction with the PD-1 ligands PD-L1 and PD-L2.[v]
Jemperli is not approved anywhere in the world for use in combination with standard-of-care chemotherapy (carboplatin-paclitaxel) followed by dostarlimab-gxly for primary advanced or recurrent endometrial cancer. In the US, Jemperli is indicated for adult patients with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer, as determined by a US 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. Jemperli is also indicated in the US for patients with dMMR recurrent or advanced solid tumors, as determined by a US FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. The latter indication is approved in the US under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication in solid tumors may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).