Merck Announces Positive Top-line Results from Phase 3 Trial Evaluating Efficacy and Safety of GARDASIL®9 in Japanese Males
Merck (NYSE: MRK) has announced positive top-line results from its Phase 3 trial evaluating GARDASIL®9, its 9-valent Human Papillomavirus (HPV) vaccine, in Japanese males aged 16 to 26. The trial met its primary and secondary endpoints, demonstrating that a 3-dose regimen of GARDASIL 9 reduced the combined incidence of anogenital persistent infection caused by 9 types of HPV compared to placebo.
Dr. Eliav Barr, senior vice president at Merck Research Laboratories, emphasized the company's commitment to preventing HPV-related cancers through broad and equitable access globally. Merck plans to share these data with regulatory authorities in Japan and other countries to support licensure for use in males. Additionally, an ongoing confirmatory Phase 3 trial is evaluating the vaccine's efficacy in preventing HPV oral persistent infection to support effectiveness against HPV-related oropharyngeal and other head and neck cancers.
Merck (NYSE: MRK) ha annunciato risultati positivi di tossicità dal suo studio di Fase 3 che valuta GARDASIL®9, il suo vaccino 9-valente contro il Papillomavirus Umano (HPV), in maschi giapponesi di età compresa tra 16 e 26 anni. Lo studio ha raggiunto i suoi obiettivi primari e secondari, dimostrando che un regime di 3 dosi di GARDASIL 9 ha ridotto l'incidenza combinata di infezioni anogenitali persistenti causate da 9 tipi di HPV rispetto al placebo.
Il Dr. Eliav Barr, vicepresidente senior dei Merck Research Laboratories, ha sottolineato l'impegno dell'azienda nella prevenzione dei tumori correlati all'HPV attraverso un accesso ampio e equo a livello globale. Merck prevede di condividere questi dati con le autorità di regolamentazione in Giappone e in altri paesi per sostenere la licenza per l'uso negli uomini. Inoltre, uno studio di conferma di Fase 3 in corso sta valutando l'efficacia del vaccino nella prevenzione di infezioni orali persistenti da HPV per supportare l'efficacia contro i tumori orofaringei e altri tumori della testa e del collo correlati all'HPV.
Merck (NYSE: MRK) ha anunciado resultados positivos principales de su ensayo de Fase 3 que evalúa GARDASIL®9, su vacuna 9-valente contra el virus del papiloma humano (VPH), en hombres japoneses de 16 a 26 años. El ensayo cumplió con sus objetivos primarios y secundarios, demostrando que un regimen de 3 dosis de GARDASIL 9 redujo la incidencia combinada de infecciones persistentes anogenitales causadas por 9 tipos de VPH en comparación con el placebo.
El Dr. Eliav Barr, vicepresidente senior de Merck Research Laboratories, enfatizó el compromiso de la empresa de prevenir cánceres relacionados con el VPH a través de un acceso amplio y equitativo a nivel mundial. Merck planea compartir estos datos con las autoridades regulatorias en Japón y otros países para respaldar la licencia de uso en hombres. Además, un ensayo confirmatorio de Fase 3 en curso está evaluando la eficacia de la vacuna para prevenir la infección oral persistente por VPH, para apoyar la efectividad contra cánceres orofaríngeos y otros cánceres de cabeza y cuello relacionados con el VPH.
머크(Merck, NYSE: MRK)는 GARDASIL®9에 대한 3상 임상 시험에서 긍정적인 주요 결과를 발표했습니다. 이 9가 인간 유두종 바이러스(HPV) 백신은 일본 남성 16세에서 26세를 대상으로 평가되었습니다. 이 시험은 주요 및 부수적 목표를 모두 달성하였으며, GARDASIL 9의 3회 접종 요법이 위약과 비교하여 9가지 HPV에 의해 발생하는 지속적인 아노겐ital 감염의 복합 발생률을 감소시켰음을 입증했습니다.
머크 연구소의 수석 부사장인 엘리압 바르 박사는 전 세계적으로 HPV 관련 암 예방을 위한 회사의 의지를 강조했습니다. 머크는 남성 사용을 위한 면허 지원을 위해 일본 및 기타 국가의 규제 당국과 이 데이터를 공유할 계획입니다. 또한, HPV 관련 구강 지속 감염 예방의 효과를 검증하기 위한 진행 중인 3상 시험이 지속 중이며, 이는 HPV 관련 구강 인두암 및 기타 머리와 목의 암에 대한 효과성을 지원합니다.
Merck (NYSE: MRK) a annoncé des résultats positifs clés de son essai de phase 3 évaluant GARDASIL®9, son vaccin human papillomavirus (HPV) à 9 valences, chez des hommes japonais âgés de 16 à 26 ans. L'essai a atteint ses objectifs principaux et secondaires, démontrant qu'un schéma de 3 doses de GARDASIL 9 a réduit l'incidence combinée des infections anogénitales persistantes causées par 9 types de HPV par rapport au placebo.
Le Dr Eliav Barr, vice-président senior des Merck Research Laboratories, a souligné l'engagement de l'entreprise à prévenir les cancers liés au HPV grâce à un accès large et équitable à une échelle mondiale. Merck prévoit de partager ces données avec les autorités de réglementation au Japon et dans d'autres pays pour soutenir l'obtention de licences pour une utilisation chez les hommes. De plus, un essai de phase 3 confirmant en cours évalue l'efficacité du vaccin dans la prévention des infections orales persistantes liées au HPV, afin de soutenir l'efficacité contre les cancers oropharyngés et d'autres cancers de la tête et du cou liés au HPV.
Merck (NYSE: MRK) hat positive Hauptergebnisse aus seiner Phase-3-Studie zu GARDASIL®9, seinem 9-valenten Human-Papillomavirus (HPV) Impfstoff, bei japanischen Männern im Alter von 16 bis 26 Jahren bekannt gegeben. Die Studie erreichte ihre primären und sekundären Endpunkte und zeigte, dass ein 3-Dosen-Schema von GARDASIL 9 die kombinierte Inzidenz anogenitaler persistierender Infektionen, die durch 9 HPV-Typen verursacht werden, im Vergleich zu Placebo reduzierte.
Dr. Eliav Barr, Senior Vice President der Merck Research Laboratories, betonte das Engagement des Unternehmens, HPV-bedingten Krebsen durch einen breiten und fairen globalen Zugang vorzubeugen. Merck plant, diese Daten mit den Zulassungsbehörden in Japan und anderen Ländern zu teilen, um die Lizenzierung für die Verwendung bei Männern zu unterstützen. Darüber hinaus wird eine laufende Bestätigungsstudie der Phase 3 durchgeführt, die die Wirksamkeit des Impfstoffs bei der Prävention von HPV-oralen Persistenzinfektionen bewertet, um die Wirksamkeit gegen HPV-bedingte oropharyngeale und andere Kopf- und Halskrebserkrankungen zu unterstützen.
- Phase 3 trial met primary and secondary endpoints for GARDASIL 9 in Japanese males
- Demonstrated reduction in anogenital persistent infection caused by 9 types of HPV
- Potential for expanded licensure for use in males in Japan and other countries
- Ongoing Phase 3 trial evaluating efficacy against HPV oral persistent infection
- None.
Insights
The Phase 3 trial results for GARDASIL®9 in Japanese males are highly significant. The vaccine demonstrated efficacy in reducing anogenital persistent HPV infections, which is a crucial step in preventing HPV-related cancers. This expands the potential patient population for GARDASIL®9, potentially leading to increased market share and
The ongoing trial for oral persistent infection prevention is particularly noteworthy, as it could open up a new market for HPV vaccination in relation to head and neck cancers. This proactive approach by Merck showcases their commitment to expanding the vaccine's indications, which could translate to long-term growth in the HPV vaccine market.
These positive results are likely to have a favorable impact on Merck's stock (NYSE: MRK). GARDASIL®9 is already a significant revenue driver for Merck, generating
Moreover, the ongoing research into oral HPV infections suggests Merck is positioning itself for future growth in the HPV vaccine market. This strategy of continuous innovation and market expansion could lead to sustained revenue growth and potentially higher profit margins, which are typically viewed positively by investors.
The positive results in Japanese males represent a significant market opportunity for Merck. Japan's healthcare system is known for its high adoption rates of preventive measures, which could lead to strong uptake of GARDASIL®9 once approved. The global HPV vaccine market is projected to reach
Merck's focus on equitable access globally aligns with increasing awareness of HPV-related cancers in men, potentially driving demand. The ongoing research into oral HPV infections could open up new market segments, further solidifying Merck's position as a leader in HPV prevention and potentially expanding their market share.
“A decade after the first approval of GARDASIL 9, Merck continues to evaluate this important vaccine in additional patient populations and remains committed to helping prevent certain HPV-related cancers through broad and equitable access globally,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “These data build on the clinical efficacy of GARDASIL 9 for the prevention of persistent infection in males and can potentially make a significant impact in addressing the global burden of certain HPV-related cancers and diseases.”
Merck plans to share these data with regulatory authorities in
About V503-064
V503-064 is a Phase 3, double-blind, placebo-controlled clinical study (NCT04635423) to evaluate the safety/tolerability and efficacy of GARDASIL 9 (V503) in preventing HPV-related anogenital persistent infection in Japanese males 16 to 26 years of age. GARDASIL 9 is commercialized in
The primary efficacy objective was to demonstrate reduction in the incidence of HPV 6/11/16/18-related 6-month anogenital persistent infection. The secondary efficacy objective was to demonstrate reduction in the incidence of HPV 31/33/45/52/58-related 6-month anogenital persistent infection. The study enrolled 1,059 participants.
About GARDASIL 9 in the
GARDASIL 9 is a vaccine indicated in females 9 through 45 years of age for the prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by human papillomavirus (HPV) Types 16, 18, 31, 33, 45, 52, and 58; cervical, vulvar, vaginal, and anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11.
GARDASIL 9 is indicated in males 9 through 45 years of age for the prevention of anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11.
The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
GARDASIL 9 does not eliminate the necessity for vaccine recipients to undergo screening for cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers as recommended by a health care provider.
GARDASIL 9 has not been demonstrated to provide protection against diseases caused by:
- HPV types not covered by the vaccine
- HPV types to which a person has previously been exposed through sexual activity
Not all vulvar, vaginal, anal, oropharyngeal and other head and neck cancers are caused by HPV, and GARDASIL 9 protects only against those vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58.
GARDASIL 9 is not a treatment for external genital lesions; cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers; or cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), or anal intraepithelial neoplasia (
Vaccination with GARDASIL 9 may not result in protection in all vaccine recipients.
Select Safety Information
GARDASIL 9 is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL 9 or GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant].
Because vaccines may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following HPV vaccination. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion. Safety and effectiveness of GARDASIL 9 have not been established in pregnant women. The most common (≥
Dosage and Administration
GARDASIL 9 should be administered intramuscularly in the deltoid or anterolateral area of the thigh.
- For individuals 9 through 14 years of age, GARDASIL 9 can be administered using a 2-dose or 3-dose schedule. For the 2-dose schedule, the second dose should be administered 6–12 months after the first dose. If the second dose is administered less than 5 months after the first dose, a third dose should be given at least 4 months after the second dose. For the 3-dose schedule, GARDASIL 9 should be administered at 0, 2 months, and 6 months.
- For individuals 15 through 45 years of age, GARDASIL 9 is administered using a 3-dose schedule at 0, 2 months, and 6 months.
About Merck
At Merck, known as MSD outside of
Forward-Looking Statement of Merck & Co., Inc.,
This news release of Merck & Co., Inc.,
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in
The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2023 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
Please see Prescribing Information for GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) at https://www.merck.com/product/usa/pi_circulars/g/gardasil_9/gardasil_9_pi.pdf and Patient Information/Medication Guide for GARDASIL 9 at https://www.merck.com/product/usa/pi_circulars/g/gardasil_9/gardasil_9_ppi.pdf
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Source: Merck & Co., Inc.
FAQ
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