AnaptysBio- and GSK-Partnered Immuno-Oncology Agent JEMPERLI (dostarlimab-gxly) plus Chemotherapy Approved in the U.S. for dMMR/MSI-H Primary Advanced or Recurrent Endometrial Cancer

• JEMPERLI is the first immuno-oncology treatment approved in the frontline setting for this patient population in combination with chemotherapy
  
• U.S. Food and Drug Administration approval represents a potential significant driver of JEMPERLI royalties
• Anticipate top-line data from two GSK Phase 3 studies that include JEMPERLI to read out in 2024: the FIRST study in first-line ovarian cancer (H1 2024) and the COSTAR study in second-line NSCLC (H2 2024)
  

SAN DIEGO, July 31, 2023 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, today announced that GSK has received U.S. Food and Drug Administration (FDA) approval for JEMPERLI (dostarlimab-gxly) plus carboplatin and paclitaxel (chemotherapy) for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer. The supplemental Biologics License Application (sBLA) supporting this new indication received Priority Review and was approved ahead of the Sept. 23, 2023 Prescription Drug User Fee Act action date.

This approval is supported by interim analysis results from Part 1 of GSK’s Phase 3 RUBY trial. The dual-primary endpoints in Part 1 are investigator-assessed progression-free survival (PFS) and overall survival (OS). The statistical analysis plan included pre-specified analyses of PFS in the dMMR/MSI-H and intent-to-treat (ITT) populations and OS in the overall population. Part 1 of the RUBY trial continues to assess the dual-primary endpoint of OS in the ITT population.

“We are excited that JEMPERLI plus chemotherapy has been FDA-approved as the first new frontline treatment option in decades for patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer,” said Daniel Faga, interim president and chief executive officer of AnaptysBio. “We believe that royalties of JEMPERLI from this approval, as well as its potential in first-line ovarian cancer, in combination with Zejula and in second-line NSCLC, in combination with cobolimab, if GSK's ongoing Phase 3 clinical trials lead to approvals, could over time contribute to our strong capital position as we focus on the development of our immune cell modulator pipeline, including our two checkpoint agonists in clinical-stage development, rosnilimab, a PD-1 agonist, and ANB032, a BTLA agonist.”