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Jan 27, 2025, 14:40

Tanja Obradovic: Lessons from 2024 for successful oncology drug development strategy

Tanja Obradovic, Oncology Medical Strategy Advisor at Mercurial AI, shared a post on LinkedIn:

“What can we learn about critical strategy steps for successful oncology drug development from results in 2024?

In 2024 we have seen 60 oncology approvals by FDA but we have also seen some very large programs designed with parallel running of numerous late-stage trials fail such as ones targeting Lag3 and TIGIT.

Many trials for these targets are still ongoing despite strong signals of high probability for negative readouts. Is it the case of hope vs rationality and how to assign levels of each?

Critical question remains of finding proper approach to limit continued development with mechanisms that do not have high chances to yield benefit and steps to increase likelihood of success.

Several key areas where strategic timely thinking may have strong impact before embarking on very large late-stage program such as evaluation of the safety and efficacy profile during early/mid-clinical development with input from wider net of practice and business experts who can independently evaluate available data and plans, assure strong voice of patients and especially critically examine validity of using PFS positivity as a strong driver of decision making.

This last point may be of special importance in case of combinations where combo toxicity may be influencing OS benefit considering news that just came in today of Lenvima (Lenvatinib) in combination with Keytruda (Pembrolizumab) failed OS in Phase III LEAP-015 trial despite positive PFS.

As navigation over pipeline management and decision-making becomes increasingly complex in oncology due to expanding approved treatments, competitive landscape across multitude of drug modalities and personalization based on increasing number of biomarkers, evolution of the strategy-defining process and key stakeholder inputs are gaining in importance.”

More posts featuring Tanja Obradovic.