CLINICAL AND REGULATORY
New LAG3 data advance Merck cancer strategy behind Keytruda
Merck has been building out a late-stage, next-generation immunotherapy pipeline behind Keytruda designed to extend the PD-1 inhibitor’s efficacy in combinations that, hopefully, don’t add toxicity. When developed as co-formulations, the combination approach may also extend patent protection of the blockbuster, which is facing key patent expirations this decade.
Coherus and Junsi plan summer resubmission for toripalimab BLA
Shanghai Junshi Biosciences and Coherus BioSciences announced that FDA has issued a complete response letter (CRL) for the BLA for toripalimab in combination with gemcitabine and cisplatin in the first-line treatment of patients with advanced recurrent or metastatic nasopharyngeal carcinoma and for toripalimab monotherapy in the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy. The CRL requests a quality process change that Coherus and Junshi Biosciences believe is readily addressable. Coherus and Junshi plan to meet with FDA directly and expect to resubmit the BLA by mid-summer 2022. The Agency also communicated in the CRL that the review timeline for the BLA resubmission would be six months, as required onsite inspections have been hindered by travel restrictions.
Roche’s lung cancer TIGIT drug missed in Phase 3 trial
Roche said that data from the SKYSCRAPER-01 trial showed tiragolumab plus Tecentriq atezolizumab did not significantly extend PFS compared with Tecentriq alone as first-line therapy in patients with PD-L1-high, locally advanced or metastatic NSCLC. The readout is a major disappointment for the program and target, which emerged as rare standouts among next-generation checkpoint inhibitors two years ago when the Genentech unit of Roche reported that tiragolumab had an additive effect on ORR in the same combination and indication at ASCO meeting. Evidence has since been emerging that tiragolumab’s effects may not extend to other cancers, especially those without high PD-L1 expression, but expectations were high for SKYSCRAPER-01. The readout follows results in March from the Phase 3 SKYSCRAPER-02 trial, in which the anti-TIGIT mAb also failed to show a PFS benefit among patients with extensive. The SKYSCRAPER-01 indication represents a much larger population than SKYSCRAPER-02.
BMS checkpoint combination misses in Phase 3 urothelial cancer study
BMS faced a setback in its checkpoint inhibitor combination strategy, designed to expand its share of the PD-1 market and deepen responses, with the Phase 3 failure of Opdivo and Yervoy in first-line urothelial carcinoma. The combination did not meet the OS endpoint versus chemo in patients expressing PD-L1 in the CheckMate-901 study. A sub-study of the combination in cisplatin-ineligible patients is ongoing. Opdivo plus Yervoy is approved to treat six other tumor types and is under review with a May 28 PDUFA date for esophageal squamous cell carcinoma.
DEALS AND FINANCING
Oncovirus company Vyriad raised $30 million in Series B round
Oncolytic virus company Vyriad raised $29.5 million in a second tranche of its series B round led by Harry Stine of Stine Seed Farms, who believes applying similar models used to generate soybean and corn strains may help develop new oncolytic viruses for cancer. Mayo Clinic, Mirae Asset, Regeneron, Southeast Minnesota Capital Fund and high net worth individuals participated in the round. Vyriad has now raised more than $100 million since 2015.