Immunocore Reports Positive Phase 1/2 Data for Brenetafusp in Melanoma Treatment
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jun 01 2026
0mins
Source: NASDAQ.COM
- 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.
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Analyst Views on IMCR
Wall Street analysts forecast IMCR stock price to rise
9 Analyst Rating
7 Buy
2 Hold
0 Sell
Strong Buy
Current: 28.550
Low
37.00
Averages
64.56
High
100.00
Current: 28.550
Low
37.00
Averages
64.56
High
100.00
About IMCR
Immunocore Holdings plc is a United Kingdom-based commercial-stage biotechnology company. The Company is engaged in the development of TCR bispecific immunotherapies, ImmTAX, which immunes mobilizing monoclonal TCRs against X disease, designed to treat a range of diseases, including cancer, autoimmune and infectious disease. The Company has a pipeline of clinical-stage programs in oncology and infectious diseases, as well as numerous pre-clinical projects. Its lead product, KIMMTRAK, is a TCR therapeutic for the treatment of patients with unresectable or metastatic uveal melanoma (mUM), in the United States, European Union, Canada, Australia and the United Kingdom. Its pipeline products include Brenetafusp, IMC-P115C, IMC-T119C, IMC-R117C, IMC-M113V, IMC-I109V, IMC-S118AI, and IMC-U120AI, among others. Its clinical programs are being conducted with patients with a range of cancers including melanoma, ovarian, lung, colorectal and others.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- 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.
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- 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.
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- FDA Meeting Outcomes: During a recent Type B meeting, the FDA confirmed that three-year data from the AMT-130 study could serve as the primary basis for a Biologics License Application (BLA), which is expected to be filed in Q3 2026, potentially accelerating market access for the therapy.
- Clinical Trial Design Adjustments: The FDA has requested that uniQure align on the confirmatory study design before BLA submission, including the consideration of a standard-of-care control group, which will impact future clinical trial strategies and timelines.
- Significant Market Potential: As the first therapy for Huntington's disease to receive FDA's Regenerative Medicine Advanced Therapy (RMAT) designation, AMT-130's potential approval could significantly enhance uniQure's market position, addressing a substantial unmet need in Huntington's disease treatment and presenting considerable commercial opportunities for the company.
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- Significant Treatment Potential: BEAM-304 aims to correct mutations in the PAH gene responsible for phenylketonuria (PKU) by lowering toxic phenylalanine levels, potentially allowing patients to maintain a normal diet and reducing reliance on specialized medical foods, which could have a profound market impact.
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- Clinical Trial Results: Mirum and Incyte's Phase II PROGRESS study of zilurgisertib showed that only 3.1% of patients developed new lesions compared to 16.7% in the placebo group, achieving an 81% reduction, indicating the drug's potential in treating this ultra-rare disease.
- Sustained Efficacy: In the open-label extension phase, no new lesions were observed among patients continuing zilurgisertib treatment at 48 weeks, with total lesion volume continuing to decline, demonstrating the drug's long-term efficacy and safety, addressing the urgent need for effective treatments.
- FDA Priority Review: Following positive clinical data, the FDA has accepted the NDA for zilurgisertib and granted Priority Review status, with a decision expected by September 26, 2026, which will expedite the drug's market entry to meet the demand for new therapies.
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See More
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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.
See More
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- 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.
See More
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- 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.
See More
