Shanghai, China, October 23, 2026 – On October 23 (Madrid time), in a Late-Breaking Abstract (LBA) oral presentation at the 2026 European Society for Medical Oncology (ESMO) Congress, Professor Lu Si from Peking University Cancer Hospital presented the extended follow-up results from the pivotal Phase II clinical study of Nolgileucel (GC101 TIL therapy), an autologous natural Tumor-Infiltrating Lymphocyte (TIL) therapy independently developed by Shanghai Juncell Therapeutics Co., Ltd., for the treatment of advanced melanoma^[1].

Professor Lu Si delivering an oral presentation at the 2026 ESMO Congress

Significant Benefit in Mucosal and Acral Melanoma

Previously at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, the results of the study were accepted as a Late-Breaking Abstract (LBA 9509) and presented orally^[2]. At the 2026 ESMO Annual Meeting, extended follow-up results were presented, along with subgroup data for mucosal and acral melanoma, further consolidating the evidence for the efficacy of Nolgileucel and demonstrating robust, sustained benefits.

Unlike cutaneous melanoma which is predominant in Western population, melanoma in East Asia is primarily composed of mucosal melanoma and acral melanoma. Based on their biological features differing from cutaneous melanoma, both the proportion and the degree of benefiting from existing treatments are significantly inferior to those seen in cutaneous melanoma, making treatment more difficult. It has been reported that an anti-PD-1 monoclonal antibody therapy achieved an objective response rate (ORR) of 0% in mucosal melanoma and 14% in acral melanoma^[3].

The MIZAR-003 study is an open-label, randomized, active-controlled, multicenter pivotal Phase II clinical trial, aiming to evaluate the efficacy and safety of Nolgileucel in patients with advanced melanoma who have failed prior PD-1 antibody therapy. All enrolled patients had failed at least two prior systemic therapies (including PD-1 antibody therapy). Most patients had mucosal or acral melanoma and distant metastases.

Compared with chemotherapy control group, the GC101 group showed PFS benefits across all subtypes. Median PFS with GC101 TIL was 4.81, 4.37, and 4.14 months in the mucosal, acral and cutaneous melanoma.

The GC101 group showed significant benefits in mucosal and acral melanoma.The hazard ratios (HR) for mucosal and acral melanoma were 0.23 and 0.41, respectively, representing to 77% and 59% reduction in the risk of disease progression or death. Significant benefits consistent with the overall population were observed in both subgroups, further supporting the efficacy advantage of Nolgileucel in patients with mucosal and acral melanoma.

Progression-Free Survival (PFS) Data of Mucosal and Acral subtypes

Juncell's Nolgileucel Demonstrates Exceptional Efficacy During Extended Follow-up

With the follow-up extended by 1.5 months, PFS benefit maintained with longer follow-up. According to the data presented, the median progression-free survival (PFS) in the GC101 treatment group was 4.37 months, which was significantly superior to 1.61 months in the chemotherapy control group (HR=0.44, 95% CI 0.28~0.70, P=0.0004). OS data remain immature, but a clear trend of benefit has been shown in the GC101 group, despite 59% crossover from the chemotherapy group, suggesting a sustained and robust survival benefit.

Progression-Free Survival (PFS) Data of MIZAR-003

The Objective Response Rate (ORR) in the GC101 treatment group was 44.0%, representing a substantial improvement over the 8.2% ORR observed in the control group. Previously disclosed data showed part of the patients in the treatment group achieved complete response (CR). During the extended follow-up, three additional patients have achieved target lesion CR, further validating the durable antitumor activity and the potential for survival benefits of Nolgileucel in patients with advanced melanoma.

Waterfall Plots of MIZAR-003

Juncell's Nolgileucel Exhibits Favorable Safety Profile

No new safety signals were observed at the extended follow-up, and GC101 demonstrated a manageable safety profile, with Grade ≥3 TEAEs primarily preconditioning-related hematologic toxicities. During extended follow-up, no treatment-related adverse events associated with TIL therapy occurred in the GC101 group, further confirming the long-term safety of Nolgileucel.

Safety Data of MIZAR-003

Nolgileucel (GC101) is the world's first TIL therapy that does not require high-intensity lymphodepletion chemotherapy or the administration of IL-2. It has delivered durable, long-term benefits in patients with advanced metastatic solid tumors who have progressed on multiple prior lines of therapy. At present, GC101 has achieved primary endpoint in the pivotal Phase II trial for advanced melanoma; the program in advanced non-small cell lung cancer has advanced to Phase II; GC101 is about to enter Phase II as postoperative adjuvant treatment for glioblastoma.

Guided by science-driven innovation, Juncell is dedicated to exploring innovative TIL cell therapies in multiple solid tumors, including melanoma, non-small cell lung cancer, cervical cancer, endometrial cancer, glioblastoma, and pancreatic cancer, to benefit a wide population of patients.

Reference:

[1] Lu S, et al. ESMO 2026, Madrid, Spain. LBA55

[2] Lu S, et al. ASCO 2026, Chicago, IL, USA. LBA 9509.

[3] Tang B, et al. Safety, Efficacy, and Biomarker Analysis of Toripalimab in Previously Treated Advanced Melanoma: Results of the POLARIS-01 Multicenter Phase II Trial. Clin Cancer Res. 2020 Aug 15;26(16):4250-4259.