Basel, Switzerland, September 13, 2026
Roche announced that its collaborator MediLink Therapeutics has reported positive Phase III clinical trial results for tarlatamab? No — the investigational therapy is Tam-Peli, a B7-H3-directed antibody-drug conjugate, in patients with relapsed small-cell lung cancer (SCLC) in China. The Phase III study demonstrated a statistically significant improvement in overall survival (OS) compared with the control treatment, marking an important milestone for the development of targeted therapies for relapsed SCLC. The results were announced by Roche on September 13, 2026, and add to growing clinical evidence supporting B7-H3 as a therapeutic target in aggressive solid tumors. Tam-Peli is being developed by MediLink, with Roche collaborating on its global development and commercialization outside specified territories.
Phase III Trial Demonstrates Significant Survival
The randomized Phase III clinical trial evaluated Tam-Peli in patients with relapsed SCLC following previous systemic treatment. According to the reported results, Tam-Peli produced a meaningful improvement in overall survival, with median OS reaching 13.3 months, compared with 9.4 months for the control arm. This represented a 54% reduction in the risk of death, with an overall survival hazard ratio of approximately 0.46. The study therefore met its primary endpoint and provides pivotal evidence for continued regulatory development of Tam-Peli in this patient population. The survival findings were accompanied by improvements in other important measures of antitumor activity. Median progression-free survival (PFS) was 7.4 months with Tam-Peli, compared with 2.8 months in the control group. The treatment also generated a substantially higher objective response rate (ORR), reported at 59.1% versus 9.7%, demonstrating a marked difference in tumor response between the treatment groups. Together, the OS, PFS and response findings provide a consistent efficacy profile supporting further development of the investigational ADC.
B7-H3 ADC Targets Relapsed Lung Cancer
Tam-Peli is an investigational B7-H3-targeted antibody-drug conjugate (ADC) designed to selectively deliver an anticancer payload to tumor cells expressing B7-H3. B7-H3 is a cell-surface protein that is frequently expressed in several solid tumors and has emerged as a potential target for antibody-based cancer therapies. By combining targeted antibody recognition with a cytotoxic payload, ADC technology aims to concentrate anticancer activity within tumor tissue while limiting exposure to healthy cells. The development of Tam-Peli is particularly relevant to relapsed SCLC, an aggressive malignancy characterized by rapid disease progression and limited treatment options after initial therapy. Patients whose disease returns following first-line treatment often have poor outcomes, creating a substantial need for therapies capable of producing durable tumor control and extending survival. The Phase III findings provide important clinical evidence for investigating B7-H3-directed treatment in this setting. The results also contribute to the broader development of precision oncology and antibody-drug conjugates, where biomarker expression can help identify tumor types that may be particularly susceptible to targeted therapeutic approaches. Continued investigation will be important to determine how B7-H3 expression, treatment response and patient characteristics influence the clinical benefit associated with Tam-Peli.
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Results Support Continued Regulatory Development
The positive Phase III findings represent a significant drug-development milestone for MediLink and Roche. The companies are expected to use the data to support subsequent regulatory discussions and potential applications for Tam-Peli in relapsed SCLC. However, the therapy remains investigational, and the Phase III results do not themselves constitute regulatory approval. The findings are also notable because they demonstrate a clinically meaningful survival advantage in a population with relapsed SCLC, where new therapeutic approaches are urgently needed. The combination of a statistically significant OS benefit, longer PFS and substantially higher response rates strengthens the clinical rationale for continued evaluation of Tam-Peli. Further regulatory and clinical-development activities will determine the potential role of the therapy in treatment practice. Additional analyses of long-term survival, safety, duration of response and patient subgroups will help characterize the benefit-risk profile of Tam-Peli as development progresses. For the biopharmaceutical sector, the Phase III results highlight the potential of B7-H3-targeted ADCs as an emerging therapeutic strategy and reinforce the importance of late-stage clinical evidence in advancing new oncology medicines toward regulatory review.
Source: Roche press release
