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FDA approved Opdivo for adjuvant treatment of patients with high-risk urothelial carcinoma


29/11/2021 | 3 minuty čtení

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Opdivo 240 mg every two weeks or 480 mg every four weeks was approved by FDA for the adjuvant treatment of patients with urothelial carcinoma who are at high risk of recurrence after undergoing radical resection, regardless of prior neoadjuvant chemotherapy, nodal involvement or PD-L1 status. 

The approval is based on the Phase 3 CheckMate -274 trial, which compared Opdivo 240 mg (n=353) to placebo (n=356). In the trial, among patients who received Opdivo, median disease-free survival was nearly twice as long as in those who received placebo (20.8 months versus 10.8 months). Opdivo reduced the risk of disease recurrence or death by 30% compared to placebo. 

Among patients whose tumors express PD-L1 ≥1%, median disease-free survival was not reached for those who received Opdivo versus 8.4 months for placebo; Opdivo reduced the risk of disease recurrence or death by 45%.

Akeso’s penpulimab received marketing approval in China for Hodgkin’s lymphoma

The PD-1 monoclonal antibody drug penpulimab co-developed by Akeso Bio and Sino Biopharmaceutical has obtained marketing approval by Chinese NMPA for treatment of patients with relapsed or refractory classic Hodgkin’s lymphoma after at least second-line systemic chemotherapy treatment. The approval is based on the ORR assessed by IRRC of 89.4% (76/85) with 47.1% (40/85) patients achieving complete response. The median follow-up time was 15.8 months. The 12-month duration of response was 74.9%. And 12-month PFS was 72.1%. China has already approved six PD-1 drugs, two from foreign companies and four developed domestically. Three were cleared for relapsed or refractory classic Hodgkin’s lymphoma, but Akeso said penpulimab is differentiated. Penpulimab is currently the only new PD-1 monoclonal antibody that applies IgG1 subtype and is modified by Fc segment, which has a lower antigen binding dissociation rate and a unique binding epitope as demonstrated by analysis on crystal structure.

China approves zimberelimab for lymphoma

China’s NMPA approved anti-PD-1 antibody zimberelimab for relapsed or refractory classical Hodgkin lymphoma. Guangzhou Gloria Biosciences has development and commercialization rights to the antibody in China, where the therapy has breakthrough designation for metastatic cervical cancer. Arcus an Gilead are developing the therapy in North America, Europe and Japan for cancers including CRPC. Ligand Pharma created the compound and said the approval marks the first for a mAb from its OmniAb antibody platform.


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%).

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