Merck & Co (MRK) Investor update summary

Oncology strategy and portfolio

• Priorities include extending KEYTRUDA into earlier-stage disease, diversifying mechanisms and using rational combinations and predictive biomarkers to improve outcomes.

• Portfolio spans immuno-oncology, precision molecular targeting and tissue targeting, including sac-TMT, MK-2010, intismeran autogene, ADCs and T-cell engagers.

• ESMO program included >90 abstracts across >20 tumor types, featuring 13 compounds and three Presidential Symposia.

Sac-TMT clinical results

• In TroFuse-005, median PFS was 7.2 vs 3.9 months (HR 0.59); interim median OS was 19.0 vs 12.1 months (HR 0.68), in previously treated advanced or recurrent endometrial cancer.

• TroFuse-005 ORR was 35% vs 17.3%, with 11.1-month duration of response; safety was consistent with prior studies and quality of life was maintained.

• In OptiTROP-Lung06, sac-TMT plus pembrolizumab improved first-line NSCLC PFS: 15.0 vs 5.7 months (HR 0.49); OS trend was favorable but immature.

• TroFuse includes 18 ongoing global Phase 3 studies, ~10 in women’s cancers; sac-TMT received FDA priority review for endometrial cancer, with a June 15, 2027 PDUFA date.

• Global Phase 3 sac-TMT combinations with KEYTRUDA or MK-2010 in first-line NSCLC are in planning.

Intismeran autogene results

• In INTerpath-001, intismeran plus KEYTRUDA reduced recurrence or death risk 42% (RFS HR 0.58) and distant metastasis or death risk 38% (DMFS HR 0.62) in resected stage IIB-IV melanoma.

• At median follow-up of 24.6 months, two-year RFS was 82.2% vs 70.0% and DMFS was 88.5% vs 80.2%; OS data remain immature, with a favorable trend.

• A prespecified sensitivity analysis showed greater benefit after six months (RFS HR 0.42; DMFS HR 0.50); safety was consistent with prior experience, with no new signals.

• INTerpath-001 enrolled 1,137 patients; treatment-related Grade 3-5 adverse events occurred in 14.2% vs 13.4% with KEYTRUDA alone.

• Late-stage development spans melanoma, NSCLC, bladder and renal cancers; intismeran autogene received FDA Breakthrough Therapy Designation with KEYTRUDA for adjuvant high-risk melanoma.