This section highlights FDA-related milestones and regulatory updates for drugs developed by Immunocore (IMCR).
Over the past two years, Immunocore has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
brenetafusp, KIMMTRAK, IMC-I109V, IMC-M113V, IMC-R117C, Tebentafusp, and IMC-F106C. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Brenetafusp FDA Regulatory Events
Brenetafusp is a drug developed by Immunocore for the following indication: patients with heavily pretreated advanced melanoma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- brenetafusp
- Announced Date:
- May 31, 2026
- Indication:
- patients with heavily pretreated advanced melanoma
Announcement
Immunocore Holdings plc today 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.
AI Summary
Immunocore said updated Phase 1/2 trial results for brenetafusp, shown at the 2026 ASCO Annual Meeting, suggest the drug may help patients with heavily pretreated advanced melanoma. In 66 patients who received brenetafusp alone, the median overall survival was 14.3 months. The 6-month survival rate was 87%, and disease control was seen in 52% of patients. The overall response rate was 12%. Results were also encouraging in patients with primary PD-1 resistance, a group with few treatment options.
The company said the findings support moving forward with the 160 mcg dose in the ongoing Phase 3 PRISM-MEL-301 trial. Brenetafusp was generally well tolerated both alone and with pembrolizumab. In the small combination group, early data showed higher response and disease control than monotherapy. Experts said the results are promising because they show possible benefit in difficult-to-treat melanoma after anti-PD-1 therapy.
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KIMMTRAK FDA Regulatory Events
KIMMTRAK is a drug developed by Immunocore for the following indication: patients with unresected or metastatic uveal melanoma (mUM).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- KIMMTRAK
- Announced Date:
- March 17, 2026
- Indication:
- patients with unresected or metastatic uveal melanoma (mUM)
Announcement
Immunocore Holdings plc announced that it will present the five-year overall survival (OS) from the KIMMTRAK (tebentafusp-tebn) Phase 3 trial in previously untreated HLA-A*02:01 positive patients with unresected or metastatic uveal melanoma (mUM), at the 2026 American Association for Cancer Research (AACR) Annual Meeting commencing on April 17, 2026.
AI Summary
Immunocore said it will present five-year overall survival (OS) results from the KIMMTRAK (tebentafusp-tebn) Phase 3 trial at the 2026 American Association for Cancer Research (AACR) Annual Meeting, which begins April 17, 2026. The data cover previously untreated HLA-A*02:01 positive patients with unresectable or metastatic uveal melanoma. The company will issue a release after the oral presentation that includes the five-year OS, which represents the longest OS follow-up reported in a randomized trial for metastatic uveal melanoma.
Beyond the abstract, the oral talk will add details on subsequent treatments in both arms, treatment beyond progression, and prognostic factors. Presentation details: title “Five-year survival with tebentafusp in previously untreated metastatic uveal melanoma in a phase 3 trial (CT029),” presenter Paul Nathan, session Advanced Cellular and Immune-Based Therapeutics, Sunday, April 19, 3:00–5:00 p.m. PT. These long-term results could inform care and sequencing options for this rare, aggressive eye cancer.
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IMC-I109V FDA Regulatory Events
IMC-I109V is a drug developed by Immunocore for the following indication: Chronic hepatitis B (HBV) infection (CHB).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- IMC-I109V
- Announced Date:
- November 7, 2025
- Indication:
- Chronic hepatitis B (HBV) infection (CHB)
Announcement
Immunocore Holdings plc announced data from its Phase 1 trial of IMC-I109V, a TCR bispecific (ENVxCD3) candidate designed to specifically eliminate HBV-infected hepatocytes expressing hepatitis B surface antigen (HBsAg) via T cell redirection.
AI Summary
Immunocore Holdings reported Phase 1 results for IMC-I109V, a bispecific T cell receptor (ENVxCD3) designed to clear HBV-infected liver cells displaying hepatitis B surface antigen (HBsAg). In 20 participants, single intravenous doses ranging from 0.8 to 20 µg showed a manageable safety profile and clear antiviral effects.
At doses of 7 µg and 20 µg, IMC-I109V induced dose-dependent drops in HBsAg, with reductions of at least 0.2 log₁₀ IU/ml in four participants. The lowest antigen levels occurred around day 8, and three of those four maintained HBsAg below baseline through four weeks. These antigen decreases coincided with expected immune activation (IL-6 rises) and temporary ALT increases, reflecting hepatocyte targeting.
Treatment-related adverse events appeared in eight participants, mainly mild flu-like symptoms and transient liver enzyme elevations. One person experienced Grade 2 cytokine release syndrome that resolved quickly with steroids. The short half-life of IMC-I109V supported rapid recovery. These findings support further studies of multiple dosing to pursue functional cures for chronic HBV.
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IMC-M113V FDA Regulatory Events
IMC-M113V is a drug developed by Immunocore for the following indication: HIV infection.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- IMC-M113V
- Announced Date:
- March 10, 2025
- Indication:
- HIV infection
Announcement
Immunocore Holdings plc today shared initial data from the multiple ascending dose (MAD) portion of its Phase 1/2 STRIVE trial of IMC-M113V, its functional cure candidate for human immunodeficiency virus (HIV).
AI Summary
Immunocore Holdings plc shared initial results from the multiple ascending dose (MAD) part of its Phase 1/2 STRIVE trial for IMC-M113V, a promising HIV functional cure candidate. In this study, 16 people living with HIV who were stable on antiretroviral therapy received weekly intravenous infusions at various dose levels. The results showed that IMC-M113V was well tolerated with no serious side effects or dose-limiting toxicities. Early data indicated a dose-dependent reduction in the active HIV reservoir and signs of viral control after treatment interruption, with some participants maintaining low viral levels during a planned 12-week break from therapy. These findings suggest that the therapy may help in controlling the virus without the need for lifelong treatment. The trial is ongoing and higher doses are being evaluated to further assess the therapeutic potential of IMC-M113V.
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IMC-R117C FDA Regulatory Events
IMC-R117C is a drug developed by Immunocore for the following indication: targeting PIWIL1 in colorectal and other gastrointestinal cancers.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- IMC-R117C
- Announced Date:
- December 17, 2024
- Indication:
- targeting PIWIL1 in colorectal and other gastrointestinal cancers.
Announcement
Immunocore Holdings plc announces that the first patient has been treated in the Phase 1/2 trial of its novel ImmTAC candidate, IMC-R117C, targeting PIWIL1 in colorectal and other gastrointestinal cancers.
AI Summary
Immunocore Holdings plc has announced that the first patient has been treated in a Phase 1/2 trial of its novel immunotherapy candidate, IMC-R117C, targeting PIWIL1 in colorectal and other gastrointestinal cancers. This trial marks the first immunotherapy effort to target PIWIL1—a cancer-testis antigen linked to rapidly growing tumors and lower survival rates in colorectal cancer. The study will evaluate the safety and clinical activity of IMC-R117C both as a standalone treatment and in combination with standard therapies. It is designed for HLA-A*02:01-positive patients whose advanced cancers express PIWIL1. The company hopes that this approach will fill significant gaps in treatment, especially for patients with advanced disease that has not responded to existing therapies, potentially offering a new path in cancer care.
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Tebentafusp FDA Regulatory Events
Tebentafusp is a drug developed by Immunocore for the following indication: Unresectable or metastatic uveal melanoma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Tebentafusp
- Announced Date:
- December 11, 2024
- Indication:
- Unresectable or metastatic uveal melanoma
Announcement
Immunocore Holdings plc announce the randomization of the first patient in the Phase 3 Adjuvant Trial in Ocular Melanoma (ATOM), investigating the safety and efficacy of tebentafusp as adjuvant treatment for uveal melanoma.
AI Summary
Immunocore Holdings plc has initiated a major milestone in the fight against uveal melanoma by randomizing the first patient in the Phase 3 Adjuvant Trial in Ocular Melanoma (ATOM). This international, open-label study, led by the European Organisation for Research and Treatment of Cancer (EORTC), is designed to evaluate whether adjuvant treatment with tebentafusp can prevent or delay relapse in high-risk uveal melanoma patients who have already undergone definitive treatments like surgery or radiotherapy. In the trial, 290 HLA-A*02:01-positive patients are expected to be enrolled and randomized to receive either tebentafusp as a monotherapy or be placed under observation. Secondary goals include assessing overall survival, safety, and quality of life, while exploratory objectives involve researching circulating tumor DNA as a potential biomarker for residual disease. This study marks a significant step toward improving long-term outcomes in patients with uveal melanoma.
Read Announcement- Drug:
- Tebentafusp
- Announced Date:
- December 3, 2024
- Indication:
- Unresectable or metastatic uveal melanoma
Announcement
Immunocore Holdings plc announced that KIMMTRAK (tebentafusp) has been recommended for funding through the National Health Service (NHS) in England by the National Institute for Health and Care Excellence (NICE).
AI Summary
Immunocore Holdings plc reached a major milestone as England’s National Institute for Health and Care Excellence (NICE) recommended funding for its innovative cancer treatment KIMMTRAK (tebentafusp) through the National Health Service (NHS). This recommendation specifically benefits HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma, a rare and aggressive form of eye cancer. Initially, NICE had given a negative decision in May 2023, but after a successful appeal in December 2023, the decision was reversed. Medical experts and patient advocates have welcomed this breakthrough, noting that KIMMTRAK is the first treatment shown to extend survival for patients with this challenging condition. The news marks a significant step forward in improving outcomes and providing new hope to patients and their families, underscoring years of dedicated research and innovation in UK science.
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IMC-F106C FDA Regulatory Events
IMC-F106C is a drug developed by Immunocore for the following indication: Multiple solid tumor types.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- IMC-F106C
- Announced Date:
- June 18, 2024
- Indication:
- Multiple solid tumor types
Announcement
Immunocore Holdings plc announces randomization of the first patient in the PRISM-MEL-301 trial, assessing the efficacy and safety of brenetafusp (IMC-F106C; PRAME-A02), in combination with nivolumab, in first-line advanced or metastatic cutaneous melanoma.
AI Summary
Immunocore Holdings plc has randomized the first patient in its global, registrational Phase 3 PRISM-MEL-301 trial. This study will evaluate the safety and effectiveness of brenetafusp (IMC-F106C; PRAME-A02) when combined with the checkpoint inhibitor nivolumab for patients with newly diagnosed advanced or metastatic cutaneous melanoma. The trial is unique as it is the first Phase 3 study to target the PRAME antigen in melanoma treatment.
The study will enroll HLA-A*02:01-positive patients and compare the combination of brenetafusp plus nivolumab against standard nivolumab therapy or nivolumab paired with relatlimab, depending on the country. Researchers aim to assess if this new approach can improve progression-free survival, overall survival, and overall response rates, offering a potential new treatment option for patients facing this aggressive form of skin cancer.
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