Shanghai Junshi Biosciences Co., Ltd. has received acceptance from China's National Medical Products Administration (NMPA) for a supplemental application regarding its drug, toripalimab. The filing seeks to expand the use of toripalimab in combination with platinum-containing chemotherapy to treat adult patients with resectable stage II-III non-small cell lung cancer (NSCLC).
The massive burden of 1.18 million annual lung cancer cases
Lung cancer remains a critical health crisis in China, with the National Clinical Research Center for Cancer reporting approximately 1.18 million new cases and 0.74 million deaths in 2024.. This accounts for nearly 23% of all new cancer diagnoses and nearly 29% of all cancer deaths in the nation.
While roughly 20% to 25% of these cases are surgically resectable at the time of diagnosis, the prognosis remains difficult; between 30% and 55% of patients experience recurrence or death following radical surgery. As reported by Shanghai Junshi Biosciences, traditional chemotherapy as a perioperative treatment has seen limited success,typically improving five-year survival rates by only about 5%.
The NEOTORCH trial's 24.8% pathological complete remission rate
The supplemental application from Shanghai Junshi Biosciences is anchored by results from the NEOTORCH clinical study (NCT04158440). This randomzied, double-blind, placebo-controlled phase 3 trial, led by Professor Shun LU of Shanghai Chest Hospital, evaluated the efficacy of toripalimab combined with platinum-containing chemotherapy.
The study, which enrolled 501 patients, demonstrated a significant leap in treatment efficacy compared to chemotherapy alone. According to the report, the pathological complete remission (pCR) rate rose to 24.8%, compared to just 1.0% in the chemotherapy-only group. Additionally, the major pathological response (MPR) rate reached 48.5%, a nearly six-fold increase over the 8.4% seen with standard chemotherapy.
Expanding the therapeutic window from stage IIIA-IIIB to stage II-III
This new application seeks to broaden the therapeutic window for toripalimab. while the National Medical Products Administration (NMPA) previously approved the drug in December 2023 for stage IIIA-IIIB non-small cell lung cancer (NSCLC), this expansion targets a wider range of patients in resectable stages II through III .
By including stage II patients , the treatment could potentially intervene earlier in the disease progression. This move follows the drug's status as the first domestically approved perioperative therapy for lung cancer in China and only the second such therapy approved worldwide.
The ambiguity of the May 2026 final analysis timeline
Despite the strong interim data, several questions remain regarding the long-term durability of these results and the specific timeline for data completion. While the interim analysis showed a clear trend toward improved overall survival (OS) with a hazard ratio of 0.62, the full extent of these benefits depends on the complete dataset.
Furthermore, the source mentions a final analysis milestone related to May 2026, leaving it unclear whether the current application relies solely on interim data or if a more comprehensive longitudinal study is still pending. It also remains to be seen how this expanded indication will impact the standard of care for patients who do not respond to the initial immunotherapy-chemotherapy combination.
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