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
IMC-F106C, IMC-M113V, IMC-R117C, and Tebentafusp. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
IMC-F106C - FDA Regulatory Timeline and 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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IMC-M113V - FDA Regulatory Timeline and 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 Timeline and 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 Timeline and 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.
Read Announcement- Drug:
- Tebentafusp
- Announced Date:
- May 29, 2024
- Indication:
- Unresectable or metastatic uveal melanoma
Announcement
Immunocore Holdings plc announced that the TEBE-AM Phase 2/3 clinical trial has been converted into a Phase 3 trial.
AI Summary
Immunocore Holdings plc announced that its TEBE-AM clinical trial evaluating KIMMTRAK for previously treated advanced cutaneous melanoma has been converted from a Phase 2/3 study to a registrational Phase 3 trial. After discussions with the FDA, the company decided that all patients randomized from the start of the trial will now be part of the intent-to-treat population for the Phase 3 study. This new phase will test three arms: KIMMTRAK as a single therapy, KIMMTRAK in combination with pembrolizumab, and a control arm. The change is expected to speed up the overall survival analysis because most patients are projected to be enrolled before the original Phase 2 overall survival data would mature. The decision supports a more robust evaluation of the treatment’s effectiveness in improving survival outcomes for patients with advanced cutaneous melanoma.
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