Immunocore (IMCR) Jefferies 2024 Global Healthcare Conference summary

Key clinical data and rationale

• Recent phase II data in melanoma for PRAME showed a 56% disease control rate in heavily pretreated patients, outperforming PD-1 plus LAG-3 combinations in similar populations.

• Disease control, rather than RECIST response, is emphasized as a predictor of progression-free survival (PFS), supported by molecular evidence such as ctDNA reductions in 42% of PRAME-positive patients.

• T cell fitness is identified as a key predictor of brenetafusp activity, with improved outcomes expected in earlier treatment lines.

• The ongoing phase III PRISM-MEL trial combines brenetafusp with nivolumab, aiming for additive efficacy, with PFS as the primary endpoint and data expected in 2027.

• Ovarian and lung cancer cohorts are progressing, with ovarian data expected in Q3 and lung in Q4, both to be presented at medical congresses.

Competitive positioning and trial design

• PRAME plus nivolumab is positioned to outperform Opdualag (PD-1 plus LAG-3) based on higher disease control rates in comparable populations.

• The phase III melanoma trial is mostly ex-U.S. due to standard-of-care differences, with 90% of sites outside the U.S.

• In the U.S., the control arm is Opdualag, while ex-U.S. it is nivolumab monotherapy.

• Ovarian cancer studies include both monotherapy and chemo combinations, focusing on platinum-resistant populations, with future plans for earlier-line studies.

• Lung cancer studies are in the signal-seeking phase, with ctDNA reductions observed but no confirmed responses yet.

KIMMTRAK program updates

• KIMMTRAK, already approved for uveal melanoma, is being studied in cutaneous melanoma with a seamless phase II/III design.

• The FDA approved converting the phase II (120 patients) into phase III, expediting the timeline by up to 12 months, with final data expected in the second half of 2026.

• The phase III will test both KIMMTRAK monotherapy and KIMMTRAK plus PD-1 versus control, with about 170 patients per arm.

• The design allows sequential testing of both investigational arms, addressing the contribution of each component.

• Additional HIV data is anticipated, with further updates expected at upcoming medical meetings.