Immatics told investors on Aug. 18 that progression and death events in its Phase 3 SUPRAME trial of anzu-cel in previously treated advanced melanoma are occurring more slowly than its models assumed. After talking with the FDA, the company will drop the planned interim analysis, run a single final progression-free survival analysis at a lower prespecified event count, and add roughly 90 patients to strengthen the overall survival comparison.
- Analysis plan: planned interim and final PFS analyses replaced by one final analysis, with 90% power retained for the primary endpoint.
- Trial size: about 90 additional patients, bringing SUPRAME to roughly 450 in total, to power overall survival.
- Timing: required randomizations due by year-end 2026, topline in the first half of 2027, BLA submission in 2027.
- Phase 1b anzu-cel at ASCO 2026: 56% confirmed ORR, 14.6-month median duration of response, 6.1-month median PFS, 16.2-month median OS, with 70% alive at 12 months and 46% at 24 months.
- Q2 financials: revenue $10.4 million against $5.4 million a year earlier, R&D $71.1 million, net loss $71.2 million.
- Cash: $448.2 million (EUR 393.4 million) at June 30, down from $534.7 million at year-end 2025, projected to last into 2028.
Immatics amended the protocol after FDA feedback
SUPRAME randomizes patients with unresectable or metastatic melanoma who have already received a PD-1 checkpoint inhibitor to anzu-cel monotherapy or investigator's choice. The primary endpoint is progression-free survival assessed by blinded independent central review under RECIST v1.1, with overall survival, objective response rate, safety and quality-of-life measures as key secondary endpoints. Slower accrual of progression and death events makes a two-look design expensive in statistical terms, and Immatics said the protocol amendments follow recent interaction with the FDA. Enrollment in North America and Europe remains on track to finish the required randomizations by year-end, and the company kept its guidance of topline data in the first half of 2027 followed by a BLA submission the same year.
We are now observing that aggregate progression and death events in the SUPRAME trial are occurring more slowly than originally modeled. Based on these results and FDA feedback, we plan to proceed directly to a streamlined final analysis, while maintaining robust statistical power for the primary PFS endpoint.
That is Harpreet Singh, Ph.D., Chief Executive Officer and Co-Founder of Immatics, in the Aug. 18 release. On the schedule he added: "We believe this approach provides the most efficient path to generating definitive data for regulatory approval and look forward to reporting topline results in the first half of 2027." The company says the extra patients are meant to strengthen anzu-cel's commercial profile through the survival endpoint.
Where the single-arm numbers stand
Updated Phase 1b data presented at the 2026 ASCO annual meeting showed a 56% confirmed objective response rate in metastatic melanoma, median duration of response of 14.6 months, median PFS of 6.1 months and median overall survival of 16.2 months, with two-year survival at 46%. Immatics described tolerability as predictable and manageable and said analyses of predictors of durable response were accepted for the ESMO Congress 2026. A Phase 2 cohort of about 30 patients with metastatic uveal melanoma is running at selected centers in the United States and Germany, intended to support a label expansion after any initial approval.
The wider PRAME portfolio moved too. IMA203CD8, the version being taken tumor-agnostic, produced a 63% ORR and 50% confirmed ORR in hard-to-treat gynecologic cancers at ASCO and a 67% ORR in synovial sarcoma, and finished Phase 1a dose escalation in mid-2026. A combination cohort pairing the PRAME bispecific IMA402 with the MAGEA4/8 bispecific IMA401 in squamous non-small cell lung cancer is enrolling, with first data expected in 2027.
Spending against a shrinking balance
Research and development costs rose to $71.1 million in the quarter from $51.4 million a year earlier, driven by SUPRAME. General and administrative expenses reached $15.8 million as commercial preparation continued. Collaboration revenue nearly doubled to $10.4 million, and the net loss narrowed to $71.2 million from $80.1 million, mostly because of foreign exchange effects in the prior-year period. Cash and other financial assets fell to $448.2 million from $534.7 million at the end of 2025, cushioned by $24.2 million net from an at-the-market offering. One partnering item landed in July: Moderna dosed the first patient in a trial of mRNA-4200, a candidate discovered under the two companies' database program using Immatics target discovery, triggering a milestone payment the company did not size.
Why This Matters to the APO|APE Reader
Immatics sizes anzu-cel's first two indications at roughly 9,000 PRAME-positive, HLA-A*02:01-positive patients a year across the United States and EU5, a Clarivate estimate that puts HLA typing and PRAME assessment in front of every referral. Anzu-cel already carries FDA orphan drug and RMAT designations, so the regulatory scaffolding is in place; what disappears with the interim analysis is any controlled efficacy signal before the 2027 topline. Until then the only randomized evidence for a PRAME-directed cell therapy in melanoma is the trial itself, still enrolling.
