Detailed narrative
KIMMTRAK Commercial Performance and Long-Term Data
KIMMTRAK demonstrated strong commercial performance, achieving $223 million in net revenue for H1 FY26, a 16% year-over-year increase, and $116 million in Q2 FY26 net sales, up 18% year-over-year. The US contributed $75 million to Q2 sales, with underlying sequential growth of 3% after normalizing for a $6 million wholesaler stocking event. The drug has achieved over 70% penetration across major markets, including 70% of US prescriptions from the community setting, with a stable duration of therapy of 14 months. Landmark 5-year overall survival data presented at AACR showed KIMMTRAK doubled the likelihood of survival at 5 years (16% OS rate vs. 8% for investigator's choice), with 44% of 5-year survivors receiving KIMMTRAK as their only treatment.
Melanoma Pipeline Expansion and Phase III Progress
Immunocore is advancing three Phase III trials in melanoma. TEBE-AM, targeting advanced cutaneous melanoma, is nearing its 540-patient enrollment target, with top-line data anticipated as early as the end of 2026. This trial aims to demonstrate an overall survival benefit in a setting with high unmet need. ATOM, in adjuvant uveal melanoma, is the only registrational trial actively enrolling in this setting, aiming to bring KIMMTRAK's benefit earlier to patients. PRISM-MEL-301, evaluating brenetafusp plus nivolumab in first-line cutaneous melanoma, has activated over 200 sites globally and targets enrollment completion by late 2027. Recent Phase I/II data for brenetafusp monotherapy in heavily pretreated melanoma showed a 17% ORR and 14.3 months median OS at the 160-microgram dose, supporting its selection for the Phase III trial.
PRAME Franchise Beyond Melanoma
The company is expanding the PRAME franchise beyond cutaneous melanoma into other tumor types, specifically ovarian and non-small cell lung cancer. Efforts include evaluating brenetafusp in combination with chemotherapy in platinum-resistant ovarian cancer and with bevacizumab in platinum-sensitive maintenance. For lung cancer, the focus is on signal detection of monotherapy across molecular subsets and combinations with standard of care. Data from these ovarian and lung cohorts are expected later this year to inform next steps. Additionally, a PRAME half-life extended candidate is in Phase I dose escalation, aiming for less frequent dosing and potentially increased overall response rates.
Autoimmune and Infectious Disease Pipeline Updates
Immunocore's modular Impax platform is enabling expansion into infectious disease and autoimmunity. The Phase I trial for the first autoimmune candidate (S118AI) in type 1 diabetes is open and actively screening, with the first patient expected to be dosed in the coming weeks. Preclinical data for S118AI, designed to bind to pre-proinsulin on pancreatic beta cells, was published in Science Advances. In HIV, enrollment for additional patients at higher dose cohorts (up to 1.2 mg) in the multiple ascending dose part of the Phase I/II trial has been completed, with results planned for early 2027. The company also expects to submit a CTA for its second autoimmune candidate by the end of 2026.
Financial Highlights and Outlook
R&D expenses for Q2 FY26 were $74 million, up from $69 million in Q2 FY25, primarily due to advancing clinical programs, including the three Phase III trials. R&D expenses are expected to modestly increase year-over-year at a slower rate than in 2025. SG&A expenses were $44 million, marginally up from $43 million in Q2 FY25, with potential incremental increases for KIMMTRAK's expansion into cutaneous melanoma. The company reported a net loss of just under $1 million, an improvement from a $10 million loss in the prior year period. Cash and marketable securities stood at $880 million as of June 30, an increase of $16 million since the start of the year. Approximately $120 million in sales-related rebates are expected in H2 FY26, normalizing to $65-70 million in FY27.