Immunocore Updates Brenetafusp Clinical Trial Results
Immunocore announced updated results from its Phase 1/2 trial evaluating brenetafusp in patients with heavily pretreated advanced melanoma. The data is presented in a poster at the 2026 American Society of Clinical Oncology, ASCO, Annual Meeting. In the 66 patients treated with brenetafusp monotherapy, the median overall survival was 14.3 months with a landmark OS rate of 87% at 6 months and 57% at 12 months. The disease control rate was 52%, while the overall response rate was 12%. Multiple measures of clinical benefit were numerically higher for patients treated with the 160 mcg dose - despite worse baseline prognostic factors compared to those treated with 40 mcg. These data support selection of 160 mcg for the ongoing Phase 3 trial evaluating brenetafusp + nivolumab vs. standard nivolumab regimens in first-line advanced melanoma. The safety profile was similar at both doses. Brenetafusp was generally well tolerated, showing a predictable, mechanism-driven safety profile as monotherapy and in combination.
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- Clinical Trial Results: Immunocore presented positive Phase 1/2 trial data for Brenetafusp at the 2026 ASCO annual meeting, showing a median overall survival (OS) of 14.3 months for 66 heavily pretreated melanoma patients, with a 6-month OS rate of 87% and a 12-month OS rate of 57%, indicating significant survival benefits for patients resistant to first-line treatments.
- Disease Control Rate: The disease control rate (DCR) for patients receiving Brenetafusp monotherapy was recorded at 52%, while the overall response rate (ORR) improved to 12% at the 160 mcg dose, providing a new treatment option for heavily pretreated melanoma patients, particularly those who failed first-line therapies.
- Combination Therapy Efficacy: Brenetafusp combined with Pembrolizumab demonstrated higher ORR and DCR, further validating its potential in melanoma treatment, especially in patients with PD-1 resistance, where the median OS reached 14.7 months and circulating tumor DNA response rate was 53%.
- Future Research Plans: Immunocore is advancing Brenetafusp in the ongoing Phase 3 PRISM-MEL-301 trial, planning to administer a 160 mcg dose in combination with Nivolumab, while also conducting Phase 1/2 trials for non-small cell lung cancer and ovarian cancer, showcasing the company's commitment to innovation in cancer immunotherapy.
- Significant Survival Rates: In 66 heavily pretreated patients with advanced melanoma receiving brenetafusp monotherapy, the 6-month overall survival rate reached 87%, indicating the drug's potential to transform treatment options for difficult-to-treat patients.
- Dose Selection Support: Data indicate that the 160 mcg dose exhibited a higher disease control rate of 52%, providing robust support for the ongoing Phase 3 PRISM-MEL-301 trial, which may enhance first-line treatment outcomes.
- Good Tolerability: Brenetafusp demonstrated favorable tolerability both as monotherapy and in combination with pembrolizumab, with common adverse events including low-grade cytokine release syndrome (56%) and rash (44%), instilling confidence in its clinical application.
- Consistent Clinical Benefits: Brenetafusp showed consistent survival rates (median OS of 14.7 months) even in patients with primary PD-1 resistance, highlighting its potential value in refractory patients and suggesting new directions for future treatment strategies.
- Significant Survival Rates: Among 66 patients treated with brenetafusp monotherapy, the 6-month overall survival rate reached 87%, with a 12-month survival rate of 57%, indicating the drug's potential efficacy in heavily pretreated melanoma patients and offering new treatment options.
- Dose Selection Support: Data indicates that the 160 mcg dose exhibited a higher disease control rate of 52%, providing strong support for the ongoing Phase 3 PRISM-MEL-301 trial aimed at evaluating the efficacy of brenetafusp in combination with nivolumab.
- Good Tolerability: Brenetafusp demonstrated good tolerability both as monotherapy and in combination with pembrolizumab, with common adverse events including low-grade cytokine release syndrome (56%) and rash (44%), indicating a manageable safety profile that supports future clinical applications.
- Efficacy in Refractory Patients: Even in patients with primary PD-1 resistance, the median overall survival with brenetafusp reached 14.7 months, highlighting its potential clinical benefits in difficult-to-treat melanoma patients and possibly changing the treatment landscape in this area.










