Suzhou, China, October 26, 2026
Innovent Biologics announced that China’s National Medical Products Administration (NMPA) has accepted for review a new indication application for sintilimab combined with nolgileucel injection (GC101) for patients with unresectable or metastatic melanoma whose disease has progressed after at least two lines of prior systemic therapy, including treatment with a PD-1 antibody. The application is supported primarily by findings from the pivotal Phase 2 MIZAR-003 clinical study, which evaluated the efficacy and safety of GC101 tumor-infiltrating lymphocyte (TIL) therapy alongside sintilimab in patients whose melanoma had failed to respond to, or who could not tolerate, previous anti-PD-1 therapy. Innovent reported that the study met its primary endpoint and showed an improvement in progression-free survival compared with chemotherapy. If approved, the proposed use would become the 11th indication for sintilimab in China, expanding its potential role in immuno-oncology. Acceptance for review does not mean the new indication has received marketing authorization.
Sintilimab and GC101 Show Progression-Free Survival Benefit
The MIZAR-003 study is a randomized, open-label, multicentre Phase 2 trial designed to evaluate GC101 TIL cell therapy with sintilimab support against chemotherapy in patients with advanced melanoma following previous anti-PD-1 treatment. According to Innovent’s October 26 announcement, patients in the experimental group had received a median of two prior lines of systemic therapy. The company reported a median progression-free survival of 4.3 months with GC101 plus sintilimab, compared with 1.6 months in the chemotherapy control group. The announcement reported a 57% reduction in the risk of disease progression or death, with a hazard ratio of 0.43, a 95% confidence interval of 0.26–0.68 and a p-value of 0.0002. These findings suggest that the combination may help extend disease control in patients whose cancer has progressed despite previous immunotherapy. The study results were initially presented as a late-breaking oral abstract at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in June. The reported findings are particularly relevant because treatment options can be limited for patients with advanced melanoma that no longer responds to PD-1 inhibitors.
GC101 Uses Tumor-Infiltrating Lymphocyte Therapy
GC101 is an investigational tumor-infiltrating lymphocyte therapy developed by Juncell Therapeutics using its proprietary DeepTIL platform. TIL therapy involves using immune cells that have entered a tumour, expanding selected cells outside the body and administering them to the patient to support an antitumour immune response. Innovent describes GC101 as a TIL therapy designed to avoid the need for high-intensity lymphodepletion chemotherapy or interleukin-2 (IL-2) administration. In the MIZAR-003 programme, GC101 is used with sintilimab, a PD-1 immune checkpoint inhibitor marketed in China as TYVYT®. Sintilimab is a monoclonal antibody that blocks the PD-1 pathway, helping restore the ability of immune cells to attack cancer. The combination brings together cellular immunotherapy and checkpoint inhibition, two approaches intended to strengthen antitumour immune activity through complementary mechanisms. Innovent reported that adverse reactions in the experimental group were manageable. Grade 3 or higher adverse reactions were mainly associated with haematological toxicity caused by preconditioning treatment, and the median duration of adverse events was eight days in the experimental group compared with 13 days in the chemotherapy control group. Further assessment will be needed to characterize the treatment’s safety and benefit-risk profile.
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NMPA Review Marks a Regulatory Milestone for Innovent
The acceptance of the new indication application marks a regulatory milestone for Innovent’s immuno-oncology portfolio and the ongoing development of GC101. The proposed indication covers patients with unresectable or metastatic melanoma following at least two prior systemic treatment lines, including anti-PD-1 therapy. This patient group has a substantial unmet need because disease progression after checkpoint inhibition can leave fewer effective treatment options. Sintilimab was co-developed by Innovent and Eli Lilly and Company and is already used for several cancer indications in China. The proposed melanoma indication would expand its clinical reach if the NMPA approves the application. GC101 is also being investigated in other oncology settings, including advanced non-small cell lung cancer, while additional research is planned in glioma. The companies will need to provide the evidence required by regulators to establish the product’s safety, efficacy and appropriate use. The NMPA has accepted the application for review; approval has not yet been announced. The decision will determine whether the sintilimab and GC101 combination can become a new treatment option for eligible patients with advanced melanoma in China.
Source: Innovent Biologics press release
