As has been the case for the past several years, industry experts will be focused on Merck at the 44^th Annual JP Morgan Healthcare Conference. While the company has good financials and performance, it faces a problem: the patent cliff coming in 2028. Keytruda, Merck’s key product, will see its patent expire in about two years.

This is a situation that Merck has been preparing for. While the company hasn’t announced its JP Morgan plans yet, whatever it does will likely be focused on its plans to strengthen its pipeline before 2028.

In 2025, the Keytruda situation was front and center. One way that Merck has been preparing for 2028 is to find ways to potentially stave off the patent expiration.

In January, 2025, Merck and Eisai announced the results of a phase 3 study evaluating the usage of Keytruda plus lenvima in combination with chemotherapy for certain types of gastroesophageal adenocarcinoma.

In a statement issued at the time,¹ Merck Research Laboratories’ vice president of global clinical development Gregory Lubiniecki said, “Locally advanced unresectable or metastatic gastroesophageal adenocarcinoma remains a challenging disease to treat and a leading cause of cancer death worldwide. These study results add to our understanding of this combination and will inform our future research as we strive to improve outcomes for more patients with cancer.”

In the same release, Dr. Corina Dutcus, senior vice president of oncology global clinical development lead at Eisai Inc, added, “Gastric and gastroesophageal cancers continue to present challenges due to their heterogeneity and generally poor prognoses. While the LEAP-015 trial did not show a statistically significant increase in overall survival, we were pleased to observe an improvement in progression-free survival and objective response rate for patients treated with Keytruda plus Lenvima in combination with chemotherapy. These results contribute to the scientific community’s collective understanding of these complex diseases and add to the body of knowledge in oncology research. We are deeply grateful to the patients, caregivers and investigators who participated in this study.”

“Pheochromocytoma and paraganglioma are rare tumors that form in and around the adrenal glands, and currently, there are no approved therapies available in the U.S. for patients with this rare disease,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “Today’s U.S. filing acceptance demonstrates our commitment to advancing novel therapies, such as WELIREG, to help treat patients with certain rare oncologic diseases. We look forward to working with the FDA to potentially provide this critical option to these patients who urgently need new innovative therapies.”

Later that month, Merck announced that FDA had granted priority review for Welireg, a treatment for advanced Pheochromocytoma and Paraganglioma.²

In a press release, Merck Research Laboratories’s president Dr. Dean Y Li said,³ “At Merck, we continue to enhance our oncology pipeline through strategic acquisitions that complement our current portfolio and advance breakthrough science to help address the needs of people with cancer worldwide. This agreement reflects the creativity and commitment of scientists and clinical development teams at Harpoon. We look forward to further evaluating HPN328 in innovative combinations with other pipeline candidates.”

2024

Merck was also focused on expanding its pipeline in 2024, when it announced the acquisition of Harpoon Therapeutics, a biopharma developing a portfolio of novel T-cell engagers.

In a press release issued at the time,³ Harpoon CEO and president Julie Eastland said, “At Harpoon, we have always been committed to advancing our cancer immunotherapy candidates to improve the lives of patients. With Merck’s recognized leadership in oncology clinical development and global commercial footprint, our lead candidate, HPN328, is well positioned moving forward. The talented, passionate and dedicated Harpoon team has made great progress over the past eight years in leveraging our research platform to develop an innovative suite of candidates, and we are pleased that Merck has recognized the significant potential of our pipeline. I want to personally thank all of our key stakeholders, including our entire team at Harpoon, trial participants, physicians and our shareholders, who have supported us.”

Sources

1. Merck and Eisai Provide Update on Phase 3 LEAP-015 Trial Evaluating KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) in Combination with Chemotherapy in Patients with Certain Types of Gastroesophageal Adenocarcinoma. Merck. January 24, 2025. Accessed December 12, 2025. https://www.merck.com/news/merck-and-eisai-provide-update-on-phase-3-leap-015-trial-evaluating-keytruda-pembrolizumab-plus-lenvima-lenvatinib-in-combination-with-chemotherapy-in-patients-with-certain-types-of-ga/
2. FDA Grants Priority Review to Merck’s Application for WELIREG® (belzutifan) for the Treatment of Patients With Advanced Pheochromocytoma and Paraganglioma (PPGL). Merck. January 27, 2025. Accessed December 12, 2025. https://www.merck.com/news/fda-grants-priority-review-to-mercks-application-for-welireg-belzutifan-for-the-treatment-of-patients-with-advanced-pheochromocytoma-and-paraganglioma-ppgl/
3. Merck to Acquire Harpoon Therapeutics, Further Diversifying Oncology Pipeline. Merck. January 8, 2024. Accessed December 12, 2025. https://www.merck.com/news/merck-to-acquire-harpoon-therapeutics-