The China NMPA Approves TYVYT® + Bevacizumab + Chemotherapy in Patients with EGFR-mutated nsqNSCLC who Progressed after EGFR-TKI Therapy
The principal investigator of the ORIENT-31 Study, Prof. Shun Lu from the Oncology Department of Shanghai Chest Hospital, stated, “Different from the western population, about half of the Chinese patients with NSCLC have EGFR mutations. EGFR-TKI targeted therapy is the first line treatment choice in NSCLC patients with EGFR sensitive mutation. However, almost all patients will eventually develop TKI-resistance and progression of disease and there are no good treatment options for EGFR-TKI failed NSCLC population[iii]. The ORIENT-31 study is globally the first prospective, randomized and double-blind Phase 3 study that demonstrated that PD-1 inhibitor ± bevacizumab combined with chemotherapy can significantly prolong PFS in EGFR-mutant non-squamous NSCLC population who have failed EGFR-TKI treatment. In addition, compared with standard platinum-based chemotherapy, sintilimab and bevacizumab combined with chemotherapy improved the ORR and DOR, showing survival benefit trend as well as improvement in quality of life. The approval of this indication brings a new treatment option for EGFR-mutated non-squamous NSCLC patients who have failed EGFR-TKI treatment, benefiting more Chinese patients.”
Share:
More News
Dr. Michael Ge, CEO of Kelun-Biotech said, “We are delighted to see the acceptance of the fifth indication application for sac-TMT. Compared to immunotherapy alone, the ADC combination with KEYTRUDA® as first-line treatment for PD-L1-positive NSCLC has achieved not only positive results in PFS, but also a trend toward benefit
“We are excited to work with Merck to advance this promising investigational combination in RAS-driven cancers,” said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. “RAS mutations activate the RAS/MAPK pathway and promote an immunosuppressive environment. Non-clinical data suggest that targeting the pathway with ERAS-0015 may complement PD-1 blockade
“Dosing the first patient in the ASPENOVA Phase 3 clinical trial represents a significant milestone in our development of azenosertib for patients with platinum-resistant ovarian cancer,” said Ingmar Bruns, M.D., Chief Medical Officer of Zentalis. “With DENALI Part 2 progressing toward a year-end readout that may support accelerated approval and
“The depth, durability, and consistency of responses observed across both the total population and BTKi-treated subsets underscore iopofosine’s potential as a meaningful new treatment option in WM and differentiate it from currently available therapies,” said Jarrod Longcor, chief operating officer of Cellectar Biosciences. “With the completion of at least 12-month