BeiGene's Immuno-oncology Portfolio Running Strong in Lung Cancer
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BeiGene, based in Cambridge, Mass., and Beijing, plans to describe the power of its lung cancer portfolio at the European Society for Medical Oncology (ESMO) Congress 2021. The conference will run from September 16-21.
The company is approaching multiple mechanisms of action in combination with its tislelizumab, an anti-PD-1 checkpoint inhibitor, with a focus on improving clinical outcomes or treating therapy-resistant cancers. In particular, it notes that non-small cell lung cancer (NSCLC) patients who have a response to frontline checkpoint inhibitor treatment eventually relapse from therapy resistance.
BeiGene is working with Mirati Therapeutics to evaluate a combination of tislelizumab and Mirati’s sitravatinib, a spectrum-selective tyrosine kinase inhibitor that it believes can reverse immunosuppressive tumor microenvironments. It is currently in Phase III. It will also present clinical data from an ongoing Phase Ib study in metastatic NSCLC, both naïve and refractory or resistant to anti-PD-(L)1 therapies.
BeiGene is also studying tislelizumab in combination with its own ociperlimab, a potent, Fc-intact anti-TIGIT-antibody. It is in Phase III development. TIGIT is another checkpoint receptor that has caught the attention of the biopharma industry. It is a co-inhibitory immune receptor expressed on multiple immune cells.
Tislelizumab is also being tested in lung cancer in combination with PI3K-delta inhibitor BGB-10188, an anti-TIM-3 antibody, BGB-A425, and chemotherapy.
“We continue to make meaningful progress with our deep immuno-oncology portfolio, including our lung cancer program of seven Phase III trials in NSCLC,” said Yong (Ben) Ben, Chief Medical Officer, Immuno-Oncology at BeiGene. “Driven by growing clinical insights, we are working to accelerate the development of tislelizumab in novel combinations in lung cancer, including with our internally discovered potent investigational anti-TIGIT antibody ociperlimab and therapeutic agents for collaborations, such as sitravatinib.”
He went on to say, “In addition, our scientists are exploring new modalities for potential combinations with tislelizumab in lung cancer and other solid tumors, and with the ongoing Novartis collaboration, tislelizumab can be leveraged with their oncology pipeline for more combination opportunities. We plan to work to realize the therapeutic potential of this differentiated checkpoint inhibitor through combinations in various tumor types for patients worldwide.”
BeiGene also announced today that the U.S. Food and Drug Administration had accepted for review its Biologics License Application (BLA) for tislelizumab for unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after previous systemic therapy. It has a Prescription Drug User Fee Act (PDUFA) date of July 12, 2022.
“Our uniquely designed anti-PD-1 antibody tislelizumab has been shown to significantly improve survival compared to chemotherapy for people with a variety of solid tumors and hematologic malignancies,” Yong Ben said. “We previously shared the compelling results at ASCO 2021 with tislelizumab significantly prolonging survival and demonstrating a favorable safety profile over chemotherapy in patients with locally advanced or metastatic ESCC, a devastating disease with an average five-year survival rate of just 5%. This BLA acceptance brings us closer to potentially providing tislelizumab as a treatment for these patients in the United States.”
The drug is already approved for five indications in China and, Yong Ben said it “has the potential to become a preferred immunotherapy option there.”
BeiGene also has a target action date of September 19 for its supplemental NDA (sNDA) for Brukinsa (zanubrutinib) for adults with marginal zone lymphoma (MZL) who have received at least one previous anti-CD20-based therapy. It is being reviewed under Priority Review status. Brukinsa is a BTK inhibitor. The sNDA was based on results from the Phase II MAGNOLIA trial in patients with relapsed or refractory (r/r) MZL.