Dean Li
President of Merck Research Labs at Merck & Co., Inc.
Thank you, Caroline. In the first quarter, we continued to make progress with a steady cadence of clinical regulatory milestones across our pipeline. Today, I will provide updates from our cardiometabolic disease portfolio, HIV and vaccine programs and close with advances in our oncology pipeline. As Rob and Caroline noted, late last month, we received approval from the FDA for WINREVAIR, our first-in-class active and signaling inhibitor for the treatment of dose living with pulmonary arterial hypertension to increase exercise capacity, improve WHO functional class and reduce the risk of clinical worsening events. WINREVAIR is a novel therapeutic option that targets a new PAH treatment pathway and is indicated to treat a broad PAH population.
This approval marks a significant step towards our goal of transforming the treatment journey for many patients with PAH. WINREVAIR is currently being reviewed by the European Medicines Agency with a decision anticipated in the second half of this year. The Phase III ZENITH and Hyperion studies evaluating patients with more advanced disease and those earlier on in their disease journey, respectively, are ongoing as well as the Phase II cadence trial evaluating WHO Group II pulmonary hypertension, a type of left heart disease. Our commitment extends to a broad range of pulmonary hypertension, informed by results from the Phase II cohort of the Phase II/III insignia PAH study evaluating MK-5475, our inhaled soluble guanylate cyclase stimulator and the STELLAR trial results for WINREVAIR, we have made the decision to focus the development of MK-5475 on WHO Group 3.1 pulmonary hypertension associated with COPD, and not further proceed in PAH. PH-COPD is an area of significant need with no specific therapies currently approved. Our HIV pipeline continues to advance.
Last month, presentations at the conference on retroviruses and opportunistic infections, reinforce progress in our strategy to develop less frequent dosing regimens for managing and treating HIV. We believe these programs have the potential to help address adherence, stigma and other challenges faced by some individuals taking daily antiretroviral pills. In collaboration with Gilead, safety and efficacy findings were presented from a Phase II study evaluating a once-weekly oral combination of islatravir, an investigation on nucleoside reverse transcriptase translocation inhibitor and lenacapavir, a first-in-class capsid inhibitor for the treatment of adults living with HIV. At 24 weeks, the trial met its primary endpoint and in a secondary endpoint maintained a high rate of viral suppression.
Additional longer-term data will be presented at a later date. In addition, safety and tolerability data were presented for MK-8527 a novel oral NRTTI candidates from two Phase I trials that evaluated ascending single dose and multiple doses in adults 18 to 55 years old, not infected with HIV. MK-8527 is being investigated as a potential monthly option for HIV pre-exposure prophylaxis. Vaccines remain an important element of our pipeline, and we are making progress across several programs. Findings from multiple Phase III trials of V116, our investigational 21 valent pneumococcal conjugate vaccine were presented at the meeting of the International Society of pneumonia and Pneumococcal Diseases last month. V116 was shown to be immunogenic for all 21 serotypes covered by the vaccine, including a pneumococcal vaccine naive and vaccine experience adults as well as those at increased risk for pneumococcal disease. If approved, V116 would be the first vaccine specifically designed to address the majority of serotypes that cause invasive pneumococcal disease in adults, ages 65 and older. The target action date is June 17.
The meeting of the CDC's Advisory Committee on immunization practices is scheduled shortly thereafter. Since the initial approval of GARDASIL, a steady flow of clinical and real-world evidence has been generated to support the favorable efficacy, effectiveness, safety and long-term durability of protection against certain human papillomavirus-related cancers and diseases in both males and females. Despite the proven public health benefit of HPV vaccination, the latest global cancer statistics from the International Agency for Research on Cancer indicate there is more to do to help increase vaccination rates.
The latest statistics from 2022 ranked cervical cancer as the fourth most common cancer globally in terms of incidents and mortality in women and the leading cause of cancer death in 37 countries, predominantly in sub-Saharan Africa, South America and Southeast Asia regions. At the Urogen Congress, last month, we disclosed plans to build on the development of GARDASIL with a new clinical program to identify a novel multivalent HPV vaccine candidate with the potential to extend protection against a broader array of HPV types.
This includes several types known to disproportionately impact African and Asian populations and individuals of African and Asian descent. First-in-human studies are scheduled to start in the fourth quarter of this year. In addition, we announced plans to conduct two randomized, double-blind multiyear clinical trials in females and males ages 16 to 26 years to examine the short- and long-term efficacy and immunogenicity of a single dose of GARDASIL-9 versus the currently approved 3-dose regimen. The goal of these studies is to generate data that clearly demonstrates whether or not a single dose of GARDASIL-9 provides comparable long-term protection to the approved regimen, while also satisfying the high standards required by regulatory authorities.
The clinical trials are anticipated to start enrolling in the fourth quarter. In oncology, we continue to focus on our 3-pillared strategy comprised of immuno-oncology, precision molecular targeting and tissue targeting agents. In immuno-oncology, September 2024 will mark a decade since the first approval of KEYTRUDA in metastatic melanoma. KEYTRUDA has since amassed approvals for 39 indication and continues to reinforce its reputation as a foundational therapy for certain types of cancer. Building on the recent FDA approval for KEYTRUDA in combination with chemotherapy for the treatment of FIGO 2014, Stage II through IVA cervical cancer, we recently announced that the pivotal KEYNOTE-A18 trial met its primary endpoint of overall survival, potentially providing a new standard of care for these patients.
Our commitment to providing better options to prevent and treat cervical cancer remain strong. Also, in women's cancer, the Phase III KEYNOTE-868 trial, known as NRG-GY018 was granted priority review by the FDA for the first-line treatment of patients with primary advanced or recurrent endometrial carcinoma. This agency has set a target action date of June 21. Outside of the U.S., the European Commission approved KEYTRUDA in combination with platinum doublet chemotherapy as neoadjuvant therapy followed by adjuvant KEYTRUDA in adult patients with non-small cell lung cancer at high risk of recurrence based on the Phase III KEYNOTE-671 study.
This marks the first approval in Europe for an anti-PD-1 PD-L1 therapy as part of a treatment regimen for the neoadjuvant followed by adjuvant treatment of resectable non-small cell lung cancer based on positive overall survival results. Next to precision targeting. Building on the success of KEYTRUDA for certain patients with non-small cell lung cancer, earlier this month, we announced the initiation of the Phase III clinical trial for MK-1084, an investigational oral selective KRAS G12C inhibitor in combination with KEYTRUDA for the first-line treatment of certain patients with metastatic non-small cell lung cancer.
The decision to proceed to Phase III was based upon early promising evidence from a Phase I study showing antitumor activity and a manageable safety profile. KRAS is one of the most prevalent oncogenes in human cancers, and G12C is the most common KRAS mutation in patients with non-small cell lung cancer. In the tissue targeting space, we are moving with speed and rigor to advance a broad pipeline of antibody drug conjugates with multiple planned and ongoing Phase III trials.
In just over six months, we have made remarkable progress in our collaboration with Daiichi Sankyo. Recently, we announced that the first patient has been dosed in the Phase II/III REJOICE OVARIAN01 trial evaluating the efficacy and safety of raludotatug deruxtecan, an investigational CDH6 directed DXDADC in patients with platinum-resistant ovarian cancer. We are poised to begin a Phase III study evaluating ifinatamab/deruxtecan, a B7-H3-directed ADC in small cell lung cancer, a notably difficult-to-treat tumor type. New treatment options are desperately needed for these patients where the prognosis remains poor.
We are pleased to have recently completed the acquisition of Harpoon Therapeutics, which provides novel T cell engagers, including MK-6070, an investigational delta-like ligand three targeting T cell engager, also being evaluated in certain types of small cell lung cancer as well as neuroendocrine tumors. Finally, please mark your calendars for the evening of Monday, June three, where we will host an investor event at ASCO in Chicago and provide an update on our diverse portfolio of immuno-oncology, precision molecular and tissue-targeting agents. Looking forward, June promises to be a busy month with three regulatory action dates, including V116 for prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults. KEYTRUDA for primary advanced or recurrent endometrial carcinoma; and patritumab/deruxtecan for advanced EGFR-mutated non-small cell lung cancer. We continue to execute on our strategy with a focus on operational excellence and look forward to providing further updates on our progress throughout the year.
And now I will turn the call back to Peter.