CLINICAL AND REGULATORY
BeiGene’s tislelizumab meets primary endpoint in Phase 3
BeiGene said that the global Phase 3 RATIONALE 306 trial of tislelizumab combined with chemotherapy met the primary endpoint of overall survival in patients with previously untreated advanced or metastatic esophageal squamous cell carcinoma. Tislelizumab is approved in China for eight indications and is under FDA and EMA review for advanced or metastatic ESCC after prior chemotherapy and EMA review for untreated advanced or metastatic non-small cell lung cancer.
IO Biotech finds use for IDO target with cancer vaccine platform
The T-Win platform from IO Biotech is proving a durable immunotherapy technology with long-term data from a 30-patient MM1636 melanoma study of IO102-IO103 at AACR. In the trial, IO102-IO103 plus Opdivo nivolumab led to an ORR of 73% in the first-line metastatic melanoma patients, with 46.7% achieving a complete response. In the PD-L1+ patients, the response rate was 94.1% and median progression-free survival was 30.9%. The company reported a three-year overall survival probability of 73%. IO102-IO103 is based on T-Win, which aims to relieve antitumor immune suppression by triggering effector T cells that destroy immunosuppressive Tregs. IO102-IO103 is a combination of peptide epitopes from IDO and PD-L1, which are both expressed on Tregs and cancer cells, to trigger effector T cell responses against the tumor cells directly and against the Tregs that suppress antitumor immunity.
Innovent disappoints with initial CD47 x PD-L1 bispecific data
Innovent Biologics presented the first clinical data from IBI322, a bispecific antibody targeting CD47 and PD-L1. The company reported four partial responses among 20 previously treated solid tumor patients in the Phase 1a/1b study, for an ORR of 20%. Three of the four responders were in the NSCLC arm, leading to an ORR of 33% (3/9) for the indication. IBI322 is part of a larger bispecific checkpoint movement advancing through the clinic that’s building on momentum from T cell engagers. Companies including Innovent are applying the bispecific checkpoint format to CD47 as a strategy to overcome the hematological toxicities that have been associated with anti-CD47 antibodies by directing the activity to the tumor microenvironment.
AstraZeneca uses voucher to speed tremelimumab’s review
FDA granted priority review to CTLA-4 inhibitor tremelimumab plus anti-PD-1 antibody Imfinzi durvalumab from AstraZeneca plc (LSE:AZN; NYSE:AZN) to treat hepatocellular carcinoma. The pharma company submitted a priority review voucher, giving it a PDUFA date in 4Q22. The combo showed an overall survival benefit over Nexavar sorafenib in the Phase 3 HIMALAYA trial.