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Merck & Co's Strategy for Success
- Jana Chisholm
- Nov 25
- 5 min read
At PharmaTell we keep Eyes on Strategic moves within the market. This week we're diving into Merck & Co's portfolio strategy to ensure future success. With the upcoming patent expiry for Keytruda, they are planning to bolster their pipeline with new products and indications via internal development and M&A.
With two late-stage trial victories for the cancer medication Welireg, Merck’s future appears somewhat brighter as the company searches for expansion prospects in the wake of Keytruda’s patent coming to an end. According to experts, one of the readouts would see Welireg inherit a sizable chunk of the renal oncology market, which is presently controlled by Merck’s aging PD-1/L1 megablockbuster. Investor confidence in Merck should be bolstered by the company’s two phase 3 successes, which include Welireg with Keytruda in post-surgery clear cell renal cell carcinoma (RCC) and Welireg plus Eisai’s Lenvima in advanced RCC patients whose illness progressed following PD-1/L1 treatment.
The Welireg-Keytruda combo in particular excited analysts, who projected that if approved, it could significantly boost Merck’s revenue. The second set of findings on the Welireg-Lenvima cocktail, however, is less evidently favourable.
Merck did not release specific findings from the two late-stage studies, which are designated LITESPARK-011 for Welireg-Lenvima and LITESPARK-022 for Keytruda combo. Merck stated that it will provide the most recent findings on the RCC combination candidates to international regulators and will provide further data at future medical discussions.
Welireg plus Keytruda demonstrated a statistically significant and clinically relevant improvement in disease-free survival compared to Keytruda alone in patients with clear cell RCC who had undergone kidney removal, meeting the main endpoint of LITESPARK-022, according to Merck. A crucial secondary endpoint of the trial will be the company’s ongoing evaluation of overall survival.
According to the company, Welireg plus Lenvima helped the LITESPARK-011 trial achieve one of its main endpoints, which was progression-free survival in patients with advanced RCC who had not responded to PD-1/L1 therapy. This combination once again showed a statistically significant and clinically meaningful improvement in PFS over Exelixis’ Cabometyx. At the time of an interim analysis, Merck reported that although there was a trend towards improvement in OS-LITESPARK-001’s second primary endpoint, the result had not yet attained statistical significance.
According to the analysts’ note, investors could not be recognising Merck’s Welireg-Keytruda combination’s potential in the adjuvant clear cell RCC market. They estimate that Welireg would be able to inherit the sizable market that Keytruda currently controls if it were granted a combination approval in clear cell RCC. This would increase Merck’s yearly U.S. revenue opportunity in the indication from $2.3 billion to $6.3 billion, and then $5.4 billion in 2029 once Keytruda loses market exclusivity.
The analysts added that because Lenvima’s inclusion in the experimental combination treatment has a higher potential for toxicity than Cabometyx monotherapy, the missing OS endpoint would probably be an important piece of information for physicians treating patients with kidney cancer. The analysts noted that Merck’s upcoming release of comprehensive LITESPARK-011 data will be a significant stimulus for Merck and its rivals in the market, but they also cautioned that the specifics of the study will determine Welireg-Lenvima’s potential success.
The Keytruda loss of exclusivity, which is anticipated later this decade, is part of Merck’s broader goal to keep up its growing momentum. Welireg was first approved by the FDA in 2021 to treat specific tumours in people with von Hippel-Lindau disease. Merck acquired Welireg when it purchased Peloton. The medication was given new indications in 2023 and 2025 for the treatment of uncommon neuroendocrine tumours and kidney cancer, respectively.
Winrevair, a potential blockbuster that has been making headway with its introduction in pulmonary arterial hypertension since receiving FDA approval last year, is another important growth driver for Merck outside of cancer.
In addition to those two medications, the business made a significant M&A move this year by acquiring Verona Pharma for $10 billion, which concluded last month. Merck added Ohtuvayre, a first-in-class medication for chronic obstructive pulmonary disease that also received its initial FDA approval last year, to the agreement.
However, Keytruda continues to be the company’s mainstay, bringing in $29.5 billion in revenue last year. The medication has accounted for about half of Merck’s total sales in recent quarters. Merck has not just focused on introducing a new growth driver to the mix in order to get ready for the drug’s loss of exclusivity. The pharmaceutical company from New Jersey just started a massive cost-cutting initiative aimed at saving $3 billion annually by the end of 2027. Merck expects to lay off roughly 6,000 employees as part of that initiative.
As interest in the soon-to-be blockbuster Winrevair grows, Merck’s $11.5 billion acquisition of Acceleron in 2021 appears to have been a wise choice. The FDA has approved a label update for the acquisition’s main component, a first-in-class activin signalling inhibitor. The medication’s label now includes information regarding its potential to lower a patient’s risk of death, lung transplantation, and hospitalisation for pulmonary arterial hypertension (PAH) thanks to the recent approval.
Results from the phase 3 Zenith trial, which included 172 PAH patients in the World Health Organisation Functional Class (FC) III or IV, who were at the highest risk of death, met their primary endpoint of time to clinical worsening to first morbidity or mortality event, which paved the way for the label update.
When Winrevair was added to maximum background therapy, the probability of these occurrences was 76% lower than when a placebo was used. Winrevair was administered subcutaneously to trial participants every three weeks, and the median duration of patient follow-up was 10.6 months. The findings were so apparent that an independent data monitoring committee, which also recommended Merck to provide Winrevair to all research participants, forced the trial to conclude at an interim stage in November of last year.
The key Zenith trial’s findings confirm Winrevair’s potential as a standard of treatment and contribute to the expanding body of data. A buildup of cells causes the lungs’ blood arteries to thicken and narrow in PAH, an uncommon and quickly developing condition that makes it difficult for the heart to pump blood to the lungs and causes shortness of breath. That can cause heart failure and raise blood pressure. Rebalancing cell signalling is how Winrevair functions.The condition affects about 40,000 persons in the United States. The majority of PAH patients are middle-aged, and the disease affects more women than men. Pulmonary hypertension (PH), a more prevalent ailment, is the initial stage of the illness and can develop into PAH.
With its initial approval in March 2024, Winrevair is off to a good start. Its revenue increased from $280 million in the first quarter to $336 million in the second. Following the release of the Zenith trial findings, analysts increased their projections for Winrevair’s 2030 sales to between $5.7 billion and $6.1 billion.
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