GENE ONLINE|News &
Opinion
Blog

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

by Joy Lin
Share To

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.  

Related Article: JPM23: Partnerships Take off From JP Morgan Healthcare Conference 2023 Day One

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.

©www.geneonline.com All rights reserved. Collaborate with us: service@geneonlineasia.com
Related Post
GeneOnline’s Weekly News Highlights: Nov 13-Nov 17
2023-11-20
GeneOnline’s Weekly News Highlights: Oct 16-Oct 20
2023-10-24
2023 ASCO Annual Meeting: Progress in Solid Tumor Treatment Research, and Promising Results in Emerging Therapies
2023-07-03
LATEST
An Interview with the Inventor of HPV Vaccine, Ian Frazer, Building a Firewall for Public Health
2024-02-29
Taiwan’s Drug Price Adjustments: Balancing Cost and Availability
2024-02-28
Neomorph Links Together With Novo Nordisk in a $1.46 Billion Molecular Glue Partnership Deal
2024-02-27
Breakthrough Study Shows Anti-IgE Antibody Safeguards Children with Multiple Food Allergies
2024-02-27
Cortisol: New Discoveries on its Impact Across Health, Culture, and Evolution
2024-02-26
Why NVIDIA’s CEO Huang Said AI Fostering Life Science:Highlighting GPU’s Applications in Biotech
2024-02-23
Revolutionary AI-Powered Respiratory Monitor Maker Gets Financial Boost with Latest Funding
2024-02-21
EVENT
Scroll to Top