Dean Y. Li
Executive Vice President & President of Merck Research Laboratories at Merck & Co., Inc.
Thank you, Caroline. It is good to be here to provide an update on our progress. In the first quarter, we continued to demonstrate progress in our pipeline. We made advances across multiple therapeutic areas, including oncology in both advanced and earlier stages of cancer as well as in cardiovascular disease and vaccines. I will also provide an update on LAGEVRIO. In oncology, we continue to build upon our strong position and execute on our strategy to expand, deepen and extend benefits to patients and diversify our imprint on cancer.
This past quarter, we achieved milestones from several tumor types as well as different stages of disease. Notably, we continue to expand our treatment impact in earlier stages of disease, where we now have six approvals from the FDA, five for KEYTRUDA and one for Lynparza. At the European Society for Medical Oncology Virtual Plenary session last month, data from the KEYNOTE-091 or PEARLS trial, evaluating KEYTRUDA for the adjuvant treatment of patients with stage IB to IIIA non-small cell lung cancer following surgical resection were presented.
At an interim analysis, KEYTRUDA has significantly improved disease-free survival in all-comers, one of the study's dual primary endpoint. The trial will continue to analyze the other dual primary endpoint of disease-free survival in patients whose tumors express high levels of PD-L1, which did not meet statistical significance at the time of the planned interim analysis. These latest data provide a strong signal for the benefit of KEYTRUDA in the adjuvant treatment study.
Additional ongoing studies in earlier stages of non-small cell lung cancer include KEYNOTE-671, which is evaluating neoadjuvant adjuvant therapy for patients with resectable II, IIIA and IIIB disease; KEYNOTE-867, which is studying stereotactic body radiotherapy with or without KEYTRUDA in adults with unresected stage one HER2 disease; and KEYLYNK-012, where we are studying KEYTRUDA in combination with Lynparza in stage III disease.
Following the approval of KEYTRUDA for the adjuvant treatment of patients 12 years and older with stage IIB or IIC melanoma following complete resection based on KEYNOTE-716, we announced that at a prespecified interim analysis, the study also met its secondary endpoint of distinct metastasis-free survival and showed continued improvement in recurrent-free survival compared to placebo. The data from KEYNOTE-716 reinforces the evidence for KEYTRUDA as adjuvant therapy for appropriate patients with stage IIB and IIC following surgery that help prevent recurrence of disease.
Now similarly, in the earlier-stage setting, along with AstraZeneca, we announced Lynparza was approved by the FDA for the adjuvant treatment of patients with germline BRCA mutations with HER2-negative high-risk early breast cancer previously treated with chemotherapy, either before or after surgery based on the OlympiA study. Further, in women's cancer, we received FDA approval for KEYTRUDA for the treatment of patients with microsatellite instability-high, or mismatch repair-deficient advanced endometrial carcinoma based on new data for KEYNOTE-158.
Now this approval is the fourth gynecologic cancer approval for KEYTRUDA and marks the fifth approval derived from the KEYNOTE-158 trial, an innovative trial designed to evaluate the use of predictive tumor biomarkers in patients receiving KEYTRUDA for advanced solid tumors. Next, the prostate cancer. Along with AstraZeneca, positive results were presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium for the PROpel trial evaluating Lynparza in combination with abiraterone as a first-line treatment for patients with metastatic castrate-resistant prostate cancer with and without mutations in a group of homologous recombination or therapy.
At a planned interim analysis, results showed an improvement in radiographic progression-free survival versus the standard of care. These early results also showed a trend towards improved overall survival. The trial will continue to assess this key secondary endpoint, and we plan to engage with health authorities to discuss the findings with the aim of bringing this important option to appropriate patients. Prostate cancer represents a significant unmet need, and we are continually gaining important insights into the biology of the tumor.
We are keen on making an impact for patients with late-stage disease. Last month, we announced the discontinuation of the KEYLYNK-010 study, evaluating the combination of KEYTRUDA and Lynparza for the treatment of metastatic castrate-resistant prostate cancer. At an interim analysis, this study showed no evidence of superiority to abiraterone and enzalutamide with respect to overall survival and radiographic progression-free survival. Our attention in metastatic castrate-resistant prostate cancer now shifts to KEYNOTE-921, a study exploring the combination of KEYTRUDA and chemotherapy; and KEYNOTE-641, which is evaluating the combination of KEYTRUDA and enzalutamide.
Outside of the United States, we continue to deliver on our regulatory strategy. Notable actions include positive CHMP opinions for cervical, MSI-high and early-stage breast cancer in Europe and approvals for the combination regimen of KEYTRUDA plus Lenvima for advanced renal cell carcinoma in Japan. And finally, to coincide with ASCO, in early June, we are planning to host an investor event in Chicago. At our recent cardiovascular investor event, we showcased our growing portfolio of programs targeting a range of conditions, including atherosclerosis, heart failure, pulmonary arterial hypertension and thrombosis.
Following the completion of our acquisition of Acceleron Pharma, we are making strong progress in advancing the development of sotatercept, a potential first-in-class soluble activin receptor type IIA fusion protein. We recently completed enrollment for the STELLAR trial ahead of schedule. STELLAR is the first of four ongoing Phase III studies evaluating sotatercept. This progress reflects enthusiasm from investigators regarding this novel investigational mechanism.
For the first time, the 2022 American Heart Association, American College of Cardiology and Heart Failure Society of America, guideline for the management of heart failure included Verquvo, which we collaborate on with our partner, Bayer, as a Class IIB recommendation for the treatment of stage C heart failure with reduced ejection fraction. The guideline highlights the submechanism of sGC such as Verquvo and the potential benefits of stimulating soluble guanylate cyclase and increasing cyclic GMP.
Based on evidence from the pioneering VICTORIA trial, Verquvo is the first drug specifically studied and approved for patients with worsening heart failure and the only drug recommended in the new guidelines for these patients. Our ongoing VICTOR study is designed to expand on the evidence to date by evaluating Verquvo in patients with chronic heart failure and reduced ejection fraction who have not experienced a recent worsening heart failure event.
Merck is uniquely positioned to meaningfully impact the treatment of patients with cardiovascular disease with at least eight potential approvals by 2030, including Verquvo and stable heart failure and sotatercept as well as our pipeline of candidates, including an inhaled soluble guanylate cyclase stimulator, a Factor XI inhibitor and an oral PCSK9 inhibitor. Next, the COVID-19 and LAGEVRIO. As the pandemic evolve, there continues to be regional surges in infection rates with the emergence of new COVID-19 variants.
Now some of these strains are resistant to specific monoclonal antibody regimens and appear able to evade some vaccine protection, highlighting the importance of testing and the availability of antiviral option. At the recent European Congress of Clinical Microbiology and Infectious Diseases, we presented Phase III virology outcomes data for MOVe-OUT, adding to the growing body of evidence for the antiviral properties of LAGEVRIO. The PANORAMIC trial evaluating novel antivirals for early treatment, which is being sponsored by the University of Oxford and funded by the U.K. government and the MOVe-AHEAD trial evaluating LAGEVRIO for post-exposure prophylaxis are both ongoing.
We are working collaboratively with the European Medicines Agency to provide additional data from these trials in order to secure an approval. We remain confident in the safety and efficacy of LAGEVRIO in appropriate patients. In particular, we believe it's low propensity for drug-drug interactions makes it an important option for patients. Next, on our pneumococcal programs. Earlier this month, the FDA extended the PDUFA date for the supplemental biologics license application for VAXNEUVANCE, our 15-valent conjugate pneumococcal vaccine in infants and children to July 1, 2022.
The agency requested additional analyses of data, which we provided. Importantly, no new studies were requested. Also in our pneumococcal program, we received breakthrough therapy designation for V116, our investigational PCV that is designed to target serotypes responsible for approximately 80% of the residual invasive disease in the older adult population and includes eight unique serotypes not in currently licensed vaccine. We look forward to providing future updates.
In closing, I would like to thank Roy Baynes for his many contributions to Merck over the past eight years. As we build upon his legacy, I'm constantly reminded of Roy's business wisdom and teaching, and I'm grateful to work with a remarkable team he has trained and mentored. One of those mentees, of course, is Eliav Barr. Eliav's experience and commitment to Merck's purpose of saving and improving lives makes him the ideal leader of our global clinical development program.
Eliav has a wealth of experience, holding leadership roles across an array of therapeutic areas during his 27 years at Merck, including vaccine, infectious disease and oncology. I look forward to continuing to partner with Eliav to build upon Merck's legacy of innovation and breakthrough science. And now back to Peter.