Dean Y. Li
Executive Vice President and President, Merck Research Laboratories at Merck & Co., Inc.
Thank you, Caroline. I'm delighted to be here today to provide an overview of progress made over the past quarter. I will cover key regulatory milestones and clinical updates initially in oncology and then across the broader pipeline. As Rob highlighted, we continue to show strong momentum in our oncology pipeline, which positions us well and it's worth reiterating our goal: to potentially deliver 90-plus approvals and new indications by 2028. A recent report from the American Cancer Society noted that there has been a rapid decrease in lung cancer and melanoma death from 2014 to 2018. One factor attributed in this -- to this decline is advancements in research, including targeted therapies and immune checkpoint inhibitors. The report also note there is an urgent need to accelerate a decline in death rates for breast, prostate and other cancers, where Merck is just beginning to make an impact. We are hopeful that our contributions and the advances being made industry-wide will continue to fuel this decline.
Notably, during the last quarter, we achieved several milestones for treatments targeting women's cancer. In triple-negative breast cancer, the most aggressive subtype of breast cancers where historically treatment options have been limited, I am pleased to announce several advancements, which will improve options for patients. The first is FDA approval for a new indication in high-risk early-stage triple-negative breast cancer based on results from the pivotal Phase 3 KEYNOTE-522 study, where KEYTRUDA was evaluated in combination with chemotherapy as new adjuvant treatment and then as monotherapy adjuvant treatment post-surgery. These practice-changing event-free survival results were presented just two weeks ago, which demonstrated a remarkable 37% reduction in the risk of progression, precluding definitive surgery, local or distant recurrings, second primary malignancy or death from any cause compared to chemotherapy alone in patients.
Now, additionally, we announced positive clinically meaningful top line overall survival results from the Phase 3 KEYNOTE-355 study evaluating KEYTRUDA in combination with chemotherapy in patients with untreated metastatic triple-negative breast cancer, whose tumors express PD-L1 with a combined proportion score greater than or equal to 10. This positions KEYTRUDA to be the first anti-PD-1 therapy in combination with chemotherapy to show statistically significant overall survival in metastatic triple-negative breast cancer. We will work with regulators to expand the existing indication to include survival benefit and we'll aim to share full results soon.
Now, also for early-stage breast cancer, along with our partners at AstraZeneca, we presented results at ASCO from the Phase 3 OlympiA trial, evaluating LYNPARZA for the adjuvant treatment of certain patients with germline BRCA high-risk HER2-negative early-stage breast cancer. These findings clearly demonstrated that LYNPARZA reduce the risk of invasive breast cancer recurrence, second cancers or death by 42%. Results will be submitted to global regulatory authorities and the trial continues to evaluate overall survival.
Now, also at ASCO, with our partners at Seagen, we presented additional encouraging data from the HER2CLIMB study TUKYSA in patients with early-stage HER2-positive breast cancers. It is clear that Merck is establishing an important beachhead in breast cancer with multiple agents. The progress we are making in this area of significant unmet patient need is one example of our strategy to expand into earlier lines of therapy and our strong conviction that our oncology assets have the potential to change the way early-stage cancers are treated.
We are also making progress across women's cancer more broadly. We received an approval from the FDA for an expanded indication for the combination of KEYTRUDA and LENVIMA for the treatment of certain patients with advanced endometrial carcinoma, where along with our partners at Eisai, we showed results from the confirmatory Phase 3 KEYNOTE-775 study earlier this year.
And finally, we had positive results from the pivotal Phase 3 KEYNOTE-826 trial investigating KEYTRUDA in combination with platinum-based chemotherapy with and without bevacizumab for the first-line treatment of patients with persistent, recurrent or metastatic cervical cancer regardless of their PD-L1 status. The trial met its dual primary endpoint of overall survival and progression-free survival. Results will be presented at an upcoming medical meeting and submitted to regulatory authorities.
Additional FDA approvals this quarter included two new indications for KEYTRUDA. The first is in combination with trastuzumab and chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma based on results from the Phase 3 KEYNOTE-811 study. The second approval was an expanded indication for cutaneous squamous cell carcinoma for patients with locally advanced disease that is not curable by surgery or radiation. This was granted under accelerated approval based on the Phase 2 KEYNOTE-629 study. The FDA also granted priority review based on Phase 3 data from KEYNOTE-581 in first-line treatment of advanced renal cell carcinoma and we expect the decision in the third quarter.
Now, outside the United States, the European Commission approved a new indication for KEYTRUDA plus chemotherapy in certain patients with esophageal cancer or HER2-negative gastroesophageal junction adenocarcinoma based on results from KEYNOTE-590. And in China, LYNPARZA was granted conditional approval for certain patients with metastatic castration-resistant prostate cancer who progressed following prior treatment with certain new hormonal agents. This is the first PARP inhibitor to be approved for advanced prostate cancer in China.
Now, also at the ASCO virtual meeting, new data supporting the benefit of KEYTRUDA in earlier lines of therapy from the pivotal Phase 3 KEYNOTE-564 trial for the adjuvant treatment of certain patients with renal cell carcinoma was presented. KEYTRUDA given after surgery demonstrated a statistically significant and clinically meaningful reduction in the risk of disease recurrence or death by 32% compared to placebo. Results will be submitted to global regulatory authorities and the trial will continue to evaluate overall survival.
We are making progress on our strategy to extend the benefit of KEYTRUDA to more patients. This includes the initiation of a Phase 3 trial evaluating a subcutaneous formulation of pembrolizumab in combination with chemotherapy in patients with non-small cell lung cancer. We believe this new formulation could be an important additional option for patients. This study will be enrolling soon with a readout expected in early 2023.
And finally, belzutifan continues to make good progress with additional Phase 2 data presented at ASCO and expected FDA action date in September and a development program with three Phase 3 studies in renal cell carcinoma that are gaining momentum.
Now, turning to our broader pipeline. In response to the outbreak of SARS-CoV-2 in India, we made the decision to enable access to molnupiravir in low- and middle-income countries through voluntary license agreements with several Indian generic manufacturers. While the ongoing studies in India are recruiting a different patient population, we are encouraged by the data being generated and we look forward to continuing to help with the crisis. We remain excited by the progress of molnupiravir and the data we've seen to date, along with our partner Ridgeback Biotherapeutics, we announced the presentation of full result from the dose finding phase of Phase 2/3 studies in both outpatient and hospitalized patients at the European Congress of Clinical Microbiology & Infectious Diseases 2021. We look forward to the readout from the Phase 3 portion of this study in the October timeframe. Additionally, we posted a new Phase 3 study evaluating molnupiravir as a post-exposure prophylactic option and look forward to a readout in the first half of 2022.
In HIV, we continue to progress our islatravir development program. Our investigational nucleoside reverse transcriptase translocation inhibitor, Phase 2 data presented at the International AIDS Society meeting a few weeks ago continue to support the safety and tolerability profile of oral once-monthly islatravir in the PrEP setting. We are continuing to enroll patients across diverse populations and geographies in the Phase 3 IMPOWER trial and are moving forward with studies evaluating islatravir in treatment and prevention settings.
In vaccines, I am pleased to note the FDA approval of VAXNEUVANCE, the first in a suite of promising pneumococcal conjugate vaccine candidate for the prevention of invasive pneumococcal disease in adults 18 years and older caused by 15 serotypes. Along with immune response data showing that VAXNEUVANCE can maintain progress achieved to date based on non-inferiority to serotypes shared with PCV13, VAXNEUVANCE also induced superior immune response to PCV13 for shared serotypes 3 and for the two serotypes unique to VAXNEUVANCE, 22F and 33F. These immunogenicity data position this vaccine to offer an important new option and protection of adults from invasive pneumococcal disease. We look forward to further engagement with the ACIP, including discussing the positive results we achieved through our robust development program, studying a broad range of adult populations and clinical circumstances, including adults at increased risk.
Building on our clinical evidence for VAXNEUVANCE, we also announced that two of our Phase 3 pediatric study met their primary immunogenicity and safety endpoints in supporting potential use in healthy infants who may have previously started a pneumococcal vaccination series with PCV13 and then the catch-up setting for healthy children who have either not received pneumococcal vaccine or received a full or partial regimen with lower valency pediatric PCVs. We continue to anticipate data from our Phase 1/2 program evaluating V116, our adult-focused vaccine to readout later this year.
To conclude, I remain excited about the progress in our broader pipeline, an effort stemming from Merck Research Labs that contribute to improving options and treatments for diseases that affect people globally. We continue to deliver on our strategy with speed and urgency to harness the benefits of our cancer therapies for as many patients as possible while advancing a broad pipeline of promising vaccines and therapeutic candidates.
Now, I will turn the call back to Peter.