Chinese Binhui moves its HSV-2 based oncovirus towards US clinical trial
Binhui Biopharmaceutical’s BS-001, a recombinant human oncolytic herpes simplex virus type-2 expressing GM-CSF for the potential treatment of solid tumors, has gained an IND approval from FDA. It is the first oncovirus developed by Chinese company to start trials abroad. The candidate is designed to selectively amplify in tumor cells and express granulocyte-macrophage colony-stimulating factors to enhance antitumor immune responses. The company enrolled 54 patients with metastatic cancers. Of those, 40 were treated with single agent, while 14 received combination with anti-PD-1 antibody HX-008 under development by Akeso Biopharma. Four patients achieved partial responses, with two from the single-agent cohort and two from the combination cohort. The two responders treated with single agent had durations of response of greater than 11 months and 14 months respectively, while the other two in the combination cohort had ongoing durations of response of about 1.4 months and 2.6 months at last report. Single agent also was found to induce alterations in the tumor microenvironment, with clear increases in CD3+ and CD8+ cell density and PD-1 expression in the patients' post-treatment biopsies relative to baseline. The most common treatment-related adverse event with single agent was fever, but no dose-limiting toxicities were reported with the single agent treatment.
Roche withdraws accelerated approval for Tecentriq in TNBC
Roche voluntarily withdrew its accelerated approval for blockbuster Tecentriq atezolizumab to treat metastatic triple negative breast cancer. The PD-L1 inhibitor gained the indication in combination with Abraxane nab-paclitaxel in March 2019 based on the progression-free survival benefit shown in the Phase 3 IMpassion130 study, but a readout in the confirmatory Phase 3 IMpassion131 study showed no PFS benefit, missing the primary endpoint. Tecentriq was granted accelerated approval by FDA for metastatic TNBC indication in March 2019, making it the first immunotherapy agent to be approved in this setting. Approval was based on PFS results of the Phase 3 IMpassion130 study for people with mTNBC whose tumors express PD-L1 (≥1%).