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Merck builds cancer combinations around Keytruda with an eye on women’s health
Merck is testing whether pairing antibody-drug conjugates with Keytruda can improve treatment for breast and gynecologic cancers while helping the company prepare for its biggest drug’s patent cliff.
The strategy puts patient tolerability alongside efficacy. Merck hopes the combinations can improve outcomes without adding a significant toxicity burden, according to Dr. Shweta Jain, vice president of global clinical development at Merck.
Its investigational ADC sacituzumab tirumotecan recently improved overall and progression-free survival in a phase 3 trial in previously treated endometrial cancer. Merck is also testing ADCs alone and alongside Keytruda across several women’s cancers, with a broader goal of replacing chemotherapy in some regimens.
Prediction markets widen pharma’s risk perimeter
Prediction markets now let people wager directly on clinical trial outcomes and FDA decisions, placing a visible price on information that can move a drugmaker’s value. That has consequences — and considerations — that the industry should address immediately, according to Mark Scallon, a principal at Baker Tilly who advises life sciences companies on compliance programs, auditing and risk.
Awareness is the critical first step. Companies should map who can access tradable milestones, update training and confidentiality policies and scrutinize controls at CROs, labs, manufacturers and other third-party partners.
Prediction markets do not necessarily create a wholly new compliance problem, Scallon said. But they make confidential information more directly monetizable and widen the circle of people companies must consider when protecting sensitive milestones.
Personalized cancer vaccines hit the scale question
One of the industry’s biggest recent clinical milestones also underscored how much work remains after a scientific win. Merck and Moderna last month reported the first positive phase 3 result for a personalized mRNA cancer vaccine, although detailed efficacy data and overall survival results remain pending.
The larger commercial challenge is built into the product itself. Each vaccine requires sequencing a patient’s tumor, selecting targets and manufacturing an individualized batch — a scale-out model that must run thousands of production cycles in parallel instead of producing one standardized drug at high volume.
Moderna says it has automated a process that can produce patient-specific batches in parallel. But manufacturing speed, chain-of-identity controls, cost and access remain central obstacles. Clinical validation may arrive before the infrastructure needed to deliver these vaccines widely, making execution as consequential as the science.
