Toripalimab sNDA Under Review in China for Frontline Unresectable or Metastatic Melanoma

The National Medical Products Administration has accepted for review a supplemental new drug application (sNDA) seeking the approval of toripalimab (Tuoyi) for use in the first-line treatment of patients with unresectable or metastatic melanoma.¹

The sNDA is supported by findings from the phase 3 MELATORCH study (NCT03430297), which met its primary end point when toripalimab significantly improved progression-free survival (PFS) over dacarbazine in this population.² The toxicity profile of the PD-1 antibody proved to align with what has previously been reported, with no new safety signals observed.

“Within the last 5 years, toripalimab has become the standard therapy for second-line and beyond salvage treatment of advanced melanoma in China, which significantly altered the treatment landscape and offered groundbreaking survival benefits to many Chinese patients. However, we also recognize that treating Chinese melanoma patients presents greater challenges than treating Caucasian melanoma patients,” Professor Jun Guo, MD, PhD, principal investigator and chairman of Chinese Society of Clinical Oncology Experts Committee on Malignant Melanoma at Beijing Cancer Hospital, stated in a news release.¹ “Thus, despite PD-1 inhibitors being approved internationally for first-line treatment of melanoma and even as adjuvant therapy for early-stage patients, no immune checkpoint inhibitor has yet been approved for these indications in China. The acceptance of toripalimab’s sNDA is proof of its value and importance in earlier line treatment. We eagerly anticipate its approval, as it would allow Chinese melanoma patients to benefit from immunotherapy even earlier.”

The randomized, open-label, phase 3 study enrolled patients with histologically confirmed unresectable stage III or IV melanoma who were naive to systemic therapy, were at least 18 years of age, measurable lesion by RECIST 1.1 criteria, and an ECOG performance status of 0 or 1.³ Patients were required to have an estimated survival of at least 16 weeks. They could not have had received a prior PD-1, PD-L1, or PD-L2 therapy; BRAF-mutated disease; malignant melanoma originating from the eyes or mucosa; receipt of other antitumor therapy, including corticosteroids; or a history of active pulmonary tuberculosis.

Study participants received toripalimab at 240 mg once every 2 weeks or dacarbazine at 1000 mg/m² once every 3 weeks. In addition to PFS serving as the trial’s primary end point, secondary end points included objective response rate, duration of response, and treatment-related toxicities.

“In 2018, toripalimab made history as the first domestically developed anti-PD-1 monoclonal antibody approved for second-line and beyond treatment of advanced melanoma, leaving its brilliant mark in China’s pharmaceutical and biotech development,” Jianjun Zou, MD, PhD, general manager and chief executive officer of Junshi Biosciences, added in the news release.¹ “Today, our efforts continue with the NMPA’s acceptance of the 12th sNDA for toripalimab, and toripalimab is poised to become China’s first immunotherapy for melanoma. We will work closely with regulatory authorities to provide better clinical treatments to patients as soon as possible.”

References

1. Junshi Biosciences announces acceptance of supplemental new drug application for toripalimab as first-line treatment of unresectable/metastatic melanoma. News release. Shanghai Junshi Biosciences Co., Ltd. August 12, 2024. Accessed August 12, 2024. https://www.globenewswire.com/news-release/2024/08/12/2928508/0/en/Junshi-Biosciences-Announces-Acceptance-of-Supplemental-New-Drug-Application-for-Toripalimab-as-First-Line-Treatment-of-Unresectable-Metastatic-Melanoma.html
2. Junshi Biosciences announces primary endpoint met in phase 3 study of toripalimab for 1st-line treatment of unresectable or metastatic melanoma. News release. Shanghai Junshi Biosciences Co., Ltd. September 25, 2023. Accessed August 12, 2024. https://www.junshipharma.com/
3. A randomized, controlled, multi-center, phase III clinical study to investigate recombinant humanized PD-1 monoclonal antibody injection (JS001) versus dacarbazine as the 1st-line therapy for unresectable or metastatic melanoma (JS001). ClinicalTrials.gov. Updated August 18, 2023. Accessed August 12, 2024. https://clinicaltrials.gov/study/NCT03430297