China’s NMPA gives approval to toripalimab plus chemotherapy in first-line ES (extensive stage)small cell lung cancer

The approval is primarily supported by findings from the phase III EXTENTORCH trial (NCT04012606), which examined toripalimab or placebo plus etoposide and cisplatin/carboplatin in patients with ES-SCLC. During the 2023 ESMO Congress, investigators presented findings from the study; at the February 28, 2022, data cutoff, at a median follow-up of 11.8 months, patients who received toripalimab (n = 223) achieved a median progression-free survival (PFS) of 5.8 months vs 5.6 months among patients in the placebo arm (n = 219; HR, 0.667; 95% CI, 0.539-0.824; P = .0002). Additionally, the median overall survival (OS) was 14.6 months vs 13.3 months, respectively (HR, 0.798; 95% CI, 0.648-0.982; P = .0327).

"With the highest number of new cases and deaths, lung cancer has always been the archenemy of tumor treatment,” Jianjun Zou, MD, PhD, general manager and chief executive officer of Junshi Biosciences said in the press release. “Junshi Biosciences has continuously invested in the research and development of new drugs for lung cancer. To date, three indications have been successfully approved, covering the main subtypes of non-small cell lung cancer and SCLC, as well as patients at all stages from early to advanced. More products and indications are currently in development, and we look forward to bringing better treatment options to lung cancer patients”