China’s NMPA Gives Go Ahead to Toripalimab Plus Chemotherapy in First-Line ES-SCLC

The National Medical Products Administration (NMPA) in China has approved the supplemental new drug application (sNDA) for the PD-1–directed antibody toripalimab-tpzi (Loqtorzi) plus etoposide and platinum for the frontline treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).¹

The approval is primarily supported by findings from the phase 3 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).²

“SCLC is highly invasive, metastasizes early, and has a poor prognosis,” Ying Cheng, MD, a professor in the Department of Medical Thoracic Oncology at Jilin Cancer Hospital in Changchun, China, stated in a press release.¹ “For a long time, the standard treatment of ES-SCLC has been platinum-based chemotherapy. Although patients are responsive to the initial stage of treatment, they are prone to drug resistance. Immunotherapy, however, has opened a new chapter. The double primary end point design of PFS and OS in EXTENTORCH followed a higher statistical standard and achieved positive results for both end points. This means that compared to mono-chemotherapy, toripalimab combined with chemotherapy can significantly improve patients’ PFS and OS. The approval of toripalimab’s new indication for the first-line treatment of [patients with] ES-SCLC will provide a new, effective, safe and affordable treatment option for [patients with SCLC] in China!”

EXTENTORCH was a double-blind, placebo-controlled, multicenter study that enrolled patients with histologically or cytologically confirmed ES-SCLC with an ECOG performance status of 1 or less. Eligible patients were randomly assigned 1:1 to receive toripalimab 240 mg or placebo in combination with etoposide and cisplatin/carboplatin every 3 weeks for 4 to 6 cycles. Following combination therapy, patients received toripalimab or placebo monotherapy until disease progression, intolerable toxicity, or for a maximum of 2 years.²

The coprimary end points were investigator-assessed PFS by RECIST 1.1 and OS. The study was conducted at 51 centers across China.^1,2

Most patients in the placebo arm received at least 3 additional lines of treatment after the study (59.4%) and 25.6% subsequently received a PD-(L)1 inhibitor. Study authors noted that the safety profile of toripalimab plus chemotherapy was manageable and no new safety signals were reported.²

“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.¹ “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!”

References

1. Junshi Biosciences announces approval of the sNDA for toripalimab for the 1st-line treatment of small cell lung cancer. News release. Shanghai Junshi Biosciences Co., Ltd. June 18, 2024. Accessed June 18, 2024. https://www.globenewswire.com/news-release/2024/06/18/2900142/0/en/Junshi-Biosciences-Announces-Approval-of-the-sNDA-for-Toripalimab-for-the-1st-Line-Treatment-of-Small-Cell-Lung-Cancer.html
2. Cheng Y, Liu Y, Zhang W, et al. LBA93 EXTENTORCH: A randomized, phase III trial of toripalimab versus placebo, in combination with chemotherapy as a first-line therapy for patients with extensive stage small cell lung cancer (ES-SCLC). Ann Oncol. 2023;34(suppl 2):S1334. doi:10.1016/j.annonc.2023.10.096