Shanghai Junshi Biosciences Announces Landmark Phase III Results for Toripalimab in Resectable Stage II-III NSCLC

Key Highlights

• Toripalimab plus chemotherapy as perioperative treatment for resectable stage II-III NSCLC met primary endpoints in Phase III NEOTORCH study.
• Positive final analysis: Significant improvements in event-free survival (EFS) and major pathological response (MPR) rates.
• Company plans to expand indication to cover all resectable stage II-III NSCLC patients.
• Potential to become the standard of care in China and internationally.
• Already approved for over 40 countries; 13 indications in China, 12 included in the National Reimbursement Drug List (NRDL).

Detailed Report

Shanghai Junshi Biosciences Co., Ltd. has announced that its PD-1 monoclonal antibody, toripalimab (trade name: TUOYI, product code: JS001), combined with platinum-based doublet chemotherapy as perioperative treatment for resectable stage II-III non-small cell lung cancer (NSCLC) patients, has achieved the primary efficacy endpoints in the final analysis of its pivotal Phase III NEOTORCH clinical study.

The primary endpoints, including event-free survival (EFS) and major pathological response (MPR) rate for the entire stage II-III population, as well as MPR rate for the stage III subgroup, have all met or exceeded predefined efficacy criteria. As a result, the company will soon submit a supplemental application to regulatory authorities, seeking to expand the approved indication from resectable stage III NSCLC to all resectable stage II-III NSCLC patients.

Toripalimab: A Key Product in Immuno-Oncology
Toripalimab is the first domestically developed PD-1 monoclonal antibody approved in China and has received the prestigious “Chinese Patent Gold Award.” Over 40 clinical studies of toripalimab (across 15+ indications) have been conducted globally, including in China, the US, Europe, and Southeast Asia. To date, 13 indications are approved in mainland China, with 12 covered by the NRDL, including unique reimbursement for renal carcinoma, triple negative breast cancer, and melanoma. Three indications have also been approved in Hong Kong SAR.

Internationally, toripalimab has been approved for marketing in more than 40 countries and regions, including the US, EU, India, UK, Australia, and Singapore, and is under review in additional jurisdictions.

About the NEOTORCH Study

Lung cancer remains the most prevalent and lethal cancer worldwide, with China accounting for 1.06 million new cases and 0.73 million deaths in 2022. Surgery is possible for about 20-25% of new patients, but post-surgical recurrence rates are high (30-55%). Traditional chemotherapy only modestly improves 5-year survival rates by about 5%.

Immunotherapy, specifically PD-(L)1 inhibitors, is rapidly changing the standard of care. The NEOTORCH study is a large, randomized, double-blind, placebo-controlled, multicenter Phase III trial led by Professor Lu Shun of Shanghai Chest Hospital, enrolling 501 patients with resectable stage II-III NSCLC. It compares toripalimab plus chemotherapy versus chemotherapy alone as perioperative treatment.

Study Endpoints and Results:

• Primary endpoints: EFS (for stage III and stage II-III), MPR rate (for both stage III and stage II-III), as assessed by researchers and a blinded pathology review.
• Secondary endpoints: Overall survival (OS), EFS by independent review, pathological complete remission rate (pCR), disease-free survival (DFS), and safety.

Interim analysis in January 2023 showed that EFS was significantly improved in the toripalimab arm. These results were presented at the ASCO Plenary Series and the 2023 ASCO Annual Meeting and published in the Journal of the American Medical Association (JAMA) in January 2024.

Key Efficacy Outcomes:

• Median EFS: Not reached (toripalimab) vs. 15.1 months (chemotherapy alone), P<0.001.
• Risk reduction of disease recurrence, progression, or death by 60% (HR=0.40, 95% CI: 0.28-0.57).
• OS trend favored toripalimab (HR=0.62, 95% CI: 0.38-1.00).
• pCR rate: 24.8% (toripalimab) vs. 1.0% (control) – a 25-fold increase.
• MPR rate: 48.5% (toripalimab) vs. 8.4% (control) – a nearly 6-fold increase.

These results support expanding the indication, and the study is the first globally for a PD-1 monoclonal antibody in NSCLC perioperative treatment (including both neoadjuvant and adjuvant) showing positive EFS outcomes.

Implications for Investors and Shareholders

• This is a major clinical and regulatory milestone, potentially positioning toripalimab as the standard of care for resectable stage II-III NSCLC in China and influencing international guidelines.
• Regulatory approval for the expanded indication could significantly boost toripalimab’s market share, revenue, and international profile.
• NEOTORCH data provides a strong competitive edge, further validated by publication in JAMA and high-profile ASCO presentations.
• Toripalimab’s inclusion in the NRDL for multiple indications increases patient access and reimbursement, supporting sales growth.

In December 2023, based on interim NEOTORCH results, the National Medical Products Administration approved a supplemental new drug application for toripalimab plus chemotherapy as perioperative therapy for resectable stage IIIA-IIIB NSCLC – making it the first such approval in China and only the second worldwide. The 2024 Chinese Society of Clinical Oncology (CSCO) guidelines give this indication the highest recommendation level.

Risk Factors

The company cautions that drug development and commercialization involve significant risks and uncertainties. Investors should remain aware that further regulatory, clinical, or commercial setbacks could impact the company’s financial performance and share price. The company pledges timely disclosure of material developments as required by regulation.

Disclaimer: This article is for informational purposes only and does not constitute investment advice. Pharmaceutical R&D and commercialization are subject to high risks and uncertainties, including regulatory, clinical, and market variables. Investors should exercise caution and consult professional advisors before making investment decisions.