Dean Y. Li
Executive Vice President and President, Merck Research Laboratories at Merck & Co., Inc.
Thank you, Caroline. It's my pleasure to provide an update on our progress since the first quarter call. We continue to execute on our pipeline strategy. We are advancing the latest signs to generate medicines and vaccines that provide clear benefit for patients. Today, I will highlight recent progress in our vaccine pipeline and provide updates on our oncology program as well as LAGEVRIO.
As Rob noted, we have made significant progress across our pneumococcal portfolio. Building upon the approval in the adult indication we received a year ago, last month, we received FDA approval for our 15-valent pneumococcal conjugate vaccine, VAXNEUVANCE, an important new option to help protect pediatric populations against invasive pneumococcal disease.
VAXNEUVANCE is the first pneumococcal conjugate vaccine approved for pediatric populations in almost a decade. VAXNEUVANCE provides comparable immunogenicity for 12 shared serotypes compared to the currently available 13-valent pneumococcal conjugate vaccine, improved immunogenicity for serotype 3 and expanded coverage for serotype 22F and 33F. Serotype 3, 22F and 33F are key invasive disease-causing serotypes known to be responsible for more than a quarter of all invasive pneumococcal disease in children.
Following FDA approval, the CDC's Advisory Committee on Immunization Practices voted unanimously to endorse use of VAXNEUVANCE as an option for children under 19 years of age. Additionally, the ACIP unanimously voted to include VAXNEUVANCE in the Vaccines for Children program. We await publication of the final CDC recommendation in the morbidity and mortality weekly report.
Also in June, at the International Symposium on Pneumococci and Pneumococcal Diseases in Toronto, we presented positive results from our Phase 1/2 study evaluating V116, our investigational 21-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naive adult. V116 is designed to significantly expand coverage compared to currently licensed pneumococcal vaccines by targeting serotypes that account for 85% of all invasive pneumococcal disease cases in adults aged 65 and older in the United States as of 2019.
As a strong indicator of our progress, we recently enrolled the first patient into the STRIDE-3 trial evaluating V116 in vaccine-naive adult, the first of four current Phase 3 trial. We have taken a thoughtful and tailored approach to establishing a pipeline of pneumococcal vaccine candidate designed to afford the protection by targeting strains posing the greatest risk to specific populations. I look forward to providing additional updates on the progress of our pneumococcal program for VAXNEUVANCE, V116 and V117, our investigational candidate, specifically targeting pediatric disease.
Turning to oncology. We continue to build on the momentum in earlier-stage cancers. We announced that the FDA has accepted our application of KEYTRUDA for the adjuvant treatment for patients with non-small cell lung cancer following surgical resection based on the results of the ongoing KEYNOTE-091 trial. The FDA has set a Prescription Drug User Fee Act date of January 29, 2023. However, further data may be provided during the review process that may delay this date.
At the American Society for Clinical Oncology Meeting in June, we provided expanded analyses and presented data on new endpoints in key subgroups four, KEYNOTE-716, for the adjuvant treatment in Stage IIB and IIC melanoma, KEYNOTE-522 in neoadjuvant, adjuvant high-risk, early-stage triple-negative breast cancer and KEYNOTE-564 in adjuvant RCC.
We are also delivering on our regulatory strategy outside the United States. Notable actions include four approvals for KEYTRUDA from the European Commission based on KEYNOTE-716 for the adjuvant treatment of patients 12 years and older with completely resected Stage IIB or IIC melanoma; KEYNOTE-522 in high-risk early-stage triple-negative breast cancer; KEYNOTE-164 and KEYNOTE-158 in MSI high and/or mismatch repair deficient tumors in five different cancer types and KEYNOTE-826 in certain types of persistent recurrent or metastatic cervical cancer.
In addition, we received a positive EU CHMP opinion for adjuvant treatment with LYNPARZA for patients with certain types of high-risk early-stage breast cancer based on the Phase 3 OlympiA trial. And finally, we are encouraged by the positive readout of KEYNOTE-869 or EV-103 in first-line urothelial cancer, which is in collaboration with Seagen.
Next, I want to discuss our ongoing efforts to treat prostate cancer. Prostate cancer impacts millions of men and those with advanced disease have low rates of five year survival. We continue to generate insight about prostate cancer from our ongoing work, and we remain focused on improving patient outcomes. Business development and licensing remains a key element of our strategy to build and maintain a strong and diverse pipeline.
Earlier this month, we announced a global development and commercialization agreement with Orion for its investigational oral, steroid synthesis inhibitor, ODM-208, which is currently in Phase 2 development for the treatment of metastatic castration-resistant prostate cancer. ODM-208 targets cytochrome P450 11A1, a novel approach that is complementary to our broad-based prostate cancer program, which includes the combination of KEYTRUDA with chemotherapy based on KEYNOTE-921, KEYTRUDA with anti-androgen therapy based on KEYNOTE-641 and KEYNOTE-991 and Lynparza with anti-androgen therapy based on the PROpel trial.
Next, to COVID-19 and LAGEVRIO. The pandemic persist and SARS-CoV-2 continues to evolve. There are solid emerging evidence for the threat of resistance to antibody therapies from Omicron variants, notably B4 and B5. The rate of transmission and increased hospitalizations with these variants reinforces the need for multiple effective antiviral treatment options, especially for those most vulnerable. For high-risk patients, evidence continues to show that prompt therapeutic intervention improved outcome.
Importantly, a large proportion of high-risk individuals, including older adults, are likely receiving additional medications for chronic conditions. LAGEVRIO's low propensity for drug-drug interaction avoids the need to adjust existing dosing regimen and monitor liver and kidney functions during treatment, which can facilitate timely intervention for appropriate patients. Recently, data reported from Denmark, Hong Kong and Poland have provided support for the utility of LAGEVRIO in real-world settings. We plan to share more data as they become available.
To conclude, I am proud of the advancements across our pipeline to date and look forward to providing further updates on our scientific progress in the future.
And now I will turn the call back to Peter.