Oriana Ciani & Denis Lacombe: Overall Survival and Surrogate Endpoints in Early Oncology Approvals

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with two experts on evidence standards for early oncology access at ISPOR Europe 2025 in Glasgow, Scotland:

• Oriana Ciani: Associate Professor of Practice at SDA Bocconi School of Management

• Denis Lacombe: Director General at EORTC

They discuss why accelerated pathways are used in oncology, what becomes feasible and risky when patient populations are small, how surrogate endpoints such as progression-free survival can differ from overall survival and quality of life, and why post-authorization evidence generation and treatment optimization shape whether early access translates into sustained patient benefit.

Key Topics:

• Accelerated Approvals: Unmet need concepts, regulatory pathways, and access pressure in oncology.

• Rare Trial Design: Small populations, randomization feasibility, comparator constraints.

• Surrogate Endpoints: Progression-free survival, early-stage endpoints, evidence needed to validate surrogates.

• HTA Variation: Differing national standards, uncertainty handling, reimbursement timing effects.

• Treatment Optimization: Post-authorization evidence gaps, dose and duration questions, aligning evidence needs earlier.

Opinions expressed are those of the speakers. This podcast was supported by Merck Sharp & Dohme as part of the APACE project, in collaboration with GlaxoSmithKline and AstraZeneca.

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