GSK’s Jemperli granted full approval to treat endometrial cancer

CLINICAL AND REGULATORY

GSK’s Jemperli granted full approval to treat endometrial cancer

GSK is also hoping to expand the label of the PD-1 inhibitor to include rectal cancer – early data from a Phase 2 study at last year’s ASCO meeting showed a 100% complete response rate in mismatch repair-deficient rectal cancer patients. 

AstraZeneca’s checkpoint combo wins EU approval

The European Commission approved the combination of PD-L1 inhibitor Imfinzi durvalumab and CTLA-4 antagonist Imjudo tremelimumab to treat hepatocellular carcinoma and non-small cell lung cancer. The liver cancer approval covers the combination’s first-line use in patients with advanced or unresectable disease; the NSCLC approval is on top of platinum-based chemotherapy in a metastatic setting. 

Keytruda meets endpoint in first-line endometrial cancer

Keytruda is positioning to again expand its reach into earlier lines of treatment after meeting the primary endpoint as first-line therapy for endometrial cancer in the Phase 3 NRG-GY018 trial. At an interim analysis, Keytruda plus chemotherapy followed by single agent Keytruda every six weeks led to an undisclosed clinically meaningful and statistically significant improvement in PFS vs. chemotherapy alone in endometrial carcinoma patients regardless of mismatch repair status. Keytruda is approved as second-line monotherapy in the mismatch repair deficient and microsatellite instability-high endometrial cancer indications, and as second-line combination therapy with Lenvima in mismatch repair proficient endometrial cancer. 

Pfizer’s multiple myeloma bispecific under US, EU review

FDA has granted priority review to a BLA for elranatamab from Pfizer to treat multiple myeloma in a heavily pretreated setting. EMA is also reviewing the bispecific mAb targeting BCMA and CD3, which led to a 61% objective response rate in the ongoing Phase 2 Magnetis-MM3 study among patients who had already received three other classes of therapies. Pfizer hopes to evaluate elranatamab in earlier lines of therapy and has forecast   its   peak   sales   could   reach   $4 billion. 

Phase 3 setbacks for Keytruda in prostate and lung cancer

Keytruda missed the primary endpoints in a pair of Phase 3 trials to treat mCRPC and metastatic NSCLC. In KEYNOTE-641, Keytruda plus Xtandi enzalutamide and androgen deprivation therapy missed on radiographic PFS and OS to treat mCRPC patients. Keytruda also missed on OS and PFS in the Phase 3 KEYNOTE-789 study, which tested Keytruda plus pemetrexed and platinum-based chemotherapy in NSCLC patients with an EGFR mutation who had already progressed on a tyrosine kinase inhibitor, including Tagrisso Osimertinib.

DEALS AND FINANCING

Redx adds US office while Jounce shareholders eye CVR’s upside in merger

Through a planned merger with Jounce, Redx will become a NASDAQ-listed company as it prioritizes a clinical ROCK2 program and develops a pipeline of small molecules for cancer and fibrosis. The deal announcement came a day after Jounce Therapeutics said it would lay off 57% of its staff and restructure. The immunotherapy company had decided not to advance two clinical programs on its own; its shareholders will receive a contingent value right tied to their advancement. Pending the deal’s approval, Redx’s shareholders will receive 63% of the combined company, and Jounce’s shareholders the 37% balance. The company believes it will have a market value of about $425 million. The united company may invest further to develop some of Jounce’s preclinical programs, but two clinical molecules – LILRB2-targeting antibody JTX-8064 and ICOS activator vopratelimab – won’t be among them. Although data from the Phase 1/2 INNATE study of JTX-8064 and the Phase 2 SELECT trial of vopratelimab have thus far been intriguing” neither trial has created enough value to justify advancing the programs within the biotech’s walls. Within one year of the merger’s closing, if the combined company reaches a deal to sell or partner any of five Jounce programs, including JTX-8064 and vopratelimab, Jounce’s shareholders are to receive 80% of the proceeds via the CVR, with the balance going to the combined entity. The CVR also covers transactions around PD-1 inhibitor pimivalimab, LILRB4-blocking antibody JTX-1484 and LILRB1 program JTX-2134. The last two are preclinical.