Junshi’s PD-1 Antibody Meets Endpoint In Phase 3 Lung Cancer Trial

by Kathy Huang
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Junshi Biosciences’ toripalimab has met its primary endpoint of event-free survival (EFS) in the Neotorch Phase 3 Study as a perioperative treatment for operable non-small cell lung cancer (NSCLC). 

In Neotorch, the PD-1 monoclonal antibody is combined with platinum-containing doublet chemotherapy and administered around the time of the surgery.  

Based on the positive data, Junshi said it will discuss with regulatory authorities to support a supplemental New Drug Application (NDA) in the near future.  

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First Positive EFS in Phase 3 on Perioperative I-O for Lung Cancer 

Clinical trials have shown that immunotherapy can significantly improve the overall survival of patients with advanced NSCLC. However, research on operable NSCLC is relatively recent and focused on preoperative neoadjuvant or postoperative adjuvant therapy. Perioperative I-O therapy covering the whole process, including pre- and post-surgery, is expected to be a better treatment model for patients.

By inhibiting PD-1 on T-cells, torapalimab allows the immune cells to ignore the “don’t-eat-me” signal, PD-L1, which cancerous cells often express. 

Neotorch is the world’s first Phase 3 study of perioperative immunotherapy for lung cancer with a positive EFS result, said Junshi. Besides EFS, the trial will also assess the major pathological remission rate (MPR) rate as the other primary endpoint. Secondary endpoints include pathological complete remission rate (pCR rate), EFS as assessed by Independent Review Committee (IRC) and disease-free survival (DFS), overall survival (OS). 

On the safety front, the data on torapalimab aligns with known risks, with no new safety signals identified. 

Torapalimab is approved for six indications in China, ranging from melanoma to NSCLC. In the US, the FDA is reviewing the Biologics License Application (BLA) resubmission for toripalimab in combination with gemcitabine and cisplatin as first-line treatment in advanced recurrent or metastatic nasopharyngeal (NPC) and for toripalimab monotherapy for the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy.

In Europe, the European Medicines Agency (EMA) has accepted the marketing authorization application (MAA)for torapalimab in combination with platinum-containing chemotherapy for first-line advanced NPC.

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