Immunocore(US:IMCR)2026-01-09 12:11KIMMTRAK Overview - KIMMTRAK is the global standard of care in first-line metastatic uveal melanoma (mUM) with a median overall survival (OS) of 28 months, showing a 27% improvement compared to investigator's choice[7]. - The company expects moderate revenue growth for KIMMTRAK in 2026, with a market penetration estimate of over 70% in major launched markets[7]. - KIMMTRAK has the potential to benefit up to 6,000 patients per year in the US and Europe, with an estimated market opportunity of around 1,200 patients for adjuvant uveal melanoma[12][13]. - The company reported net sales of $295 million for KIMMTRAK in the first three quarters of 2025, following its approval in 2022[13]. Clinical Trials and Studies - The Phase 3 TEBE-AM trial for second-line advanced cutaneous melanoma is expected to enroll approximately 540 patients, with completion anticipated in the first half of 2026[9]. - The ongoing Phase 3 study PRISM-MEL301 is evaluating combinations of KIMMTRAK with other therapies in platinum-resistant ovarian carcinoma and other solid tumors[15]. - The Phase 3 trial PRISM-MEL-301 is currently enrolling approximately 325 patients, targeting previously untreated advanced melanoma with HLA-A*02:01[20]. - The company expects to present Phase 1 data in multiple cohorts in the second half of 2026, focusing on ovarian cancer and other indications[25]. - Upcoming milestones include completing enrollment in the Phase 3 trial for Tebentafusp and dosing the first patient in the Phase 1 trial for IMC-S118AI in type 1 diabetes in 1H 2026[42]. - Registrational trials for PRISM-MEL-301 are set to be completed by 2027[42]. Safety and Efficacy - The safety profile of Brenetafusp monotherapy was consistent with previous reports, with 92% of patients experiencing any grade treatment-related adverse events[17]. - The disease control rate (DCR) for brenetafusp in combination with nivolumab is promising, with a DCR of 100% in patients with prior CTLA-4 therapy[19]. - The median progression-free survival (mPFS) for patients treated with nivolumab + relatlimab is reported at 4.2 months, compared to 3.7 months for nivolumab alone[19]. - In the Phase 1 monotherapy study, 58% of patients achieved a DCR, with a 6-month overall survival (OS) rate of 73%[23]. - The treatment-related adverse events (TRAE) were reported in 97% of monotherapy patients, with 19% experiencing grade 3/4 TRAE[22]. Financial Position and Strategic Priorities - The preliminary unaudited cash position of Immunocore as of December 31, 2025, is subject to change pending the completion of audited financial statements[2]. - The company has a preliminary and unaudited year-end cash position of $864 million[42]. - Immunocore's strategic priorities for 2026 include expanding commercial infrastructure and launching new product candidates[2]. New Product Candidates and Research - The company is evaluating brenetafusp in ovarian cancer, with an estimated 16,000 patients eligible for treatment in the first-line setting[25]. - The novel ImmTAC candidate IMC-R117C targets PIWIL1 for colorectal and gastrointestinal cancers, with an estimated 20,000 colorectal cancer patients positive for PIWIL1[28]. - The ongoing Phase 1 trial for IMC-M113V1 aims to determine safety and anti-viral activity in people living with HIV, with a target dose range of 60-300 mcg[31]. - Data from Phase 1/2 combinations in ovarian cancer and monotherapy in NSCLC for Brenetafusp are anticipated[42]. - Initial data from the Phase 1 trial in multiple solid tumors for PRAME-A02-HLE is expected[42]. - The company plans to submit an IND/CTA for a CD1a x PD1 (non-HLA restricted) trial in atopic dermatitis in 2H 2026[42].