Pfizer Announces Top-Line Results of ABRYSVO® for RSV in Immunocompromised Adults
Pfizer (NYSE: PFE) announced positive top-line results from substudy B of the Phase 3 MONeT trial, evaluating ABRYSVO vaccine in immunocompromised adults at risk of severe RSV-associated lower respiratory tract disease. The study involved 203 adults across four groups: non-small cell lung cancer patients, hemodialysis patients, autoimmune disorder patients on immunomodulator therapy, and solid organ transplant recipients.
Key findings:
- ABRYSVO was well-tolerated with a safety profile consistent with previous studies
- A single 120 µg dose generated strong neutralizing responses against RSV-A and RSV-B across all cohorts and age groups
- Results support ABRYSVO's potential to address unmet needs in vulnerable populations aged 18-59
Pfizer plans to share these findings at an upcoming scientific conference and submit data to regulatory agencies for review.
Pfizer (NYSE: PFE) ha annunciato risultati positivi dalla substudio B della fase 3 della sperimentazione MONeT, che valuta il vaccino ABRYSVO in adulti immunocompromessi a rischio di malattie gravi delle vie respiratorie inferiori associate a RSV. Lo studio ha coinvolto 203 adulti suddivisi in quattro gruppi: pazienti con carcinoma polmonare non a piccole cellule, pazienti in emodialisi, pazienti con malattie autoimmuni in terapia immunomodulante e riceventi di trapianti di organi solidi.
Risultati chiave:
- ABRYSVO è stato ben tollerato, con un profilo di sicurezza coerente con studi precedenti
- Una singola dose di 120 µg ha generato forti risposte neutralizzanti contro RSV-A e RSV-B in tutti i gruppi e fasce d'età
- I risultati supportano il potenziale di ABRYSVO di soddisfare le esigenze non soddisfatte delle popolazioni vulnerabili di età compresa tra 18-59 anni
Pfizer intende condividere questi risultati in una prossima conferenza scientifica e presentare i dati alle agenzie regolatorie per la revisione.
Pfizer (NYSE: PFE) anunció resultados positivos de la subestudio B del ensayo MONeT de fase 3, que evalúa la vacuna ABRYSVO en adultos inmunocomprometidos en riesgo de enfermedades graves del tracto respiratorio inferior asociadas al RSV. El estudio involucró a 203 adultos en cuatro grupos: pacientes con cáncer de pulmón no microcítico, pacientes en diálisis, pacientes con enfermedades autoinmunes en terapia inmunomoduladora y receptores de trasplantes de órganos sólidos.
Hallazgos clave:
- ABRYSVO fue bien tolerado, con un perfil de seguridad consistente con estudios anteriores
- Una sola dosis de 120 µg generó respuestas neutralizantes fuertes contra RSV-A y RSV-B en todos los grupos y edades
- Los resultados apoyan el potencial de ABRYSVO para abordar necesidades no satisfechas en poblaciones vulnerables de 18 a 59 años
Pfizer planea compartir estos hallazgos en una próxima conferencia científica y presentar los datos a las agencias regulatorias para su revisión.
화이자 (NYSE: PFE)는 면역 저하 성인에서 심각한 RSV 관련 하부 호흡기 질환의 위험에 처한 ABRYSVO 백신을 평가하는 3상 MONeT 시험의 하위 연구 B에서 긍정적인 최종 결과를 발표했습니다. 이 연구는 비소세포 폐암 환자, 혈액투석 환자, 면역 조절 요법을 받는 자가면역 질환 환자, 장기 이식 수혜자 등 네 그룹의 203명의 성인을 포함했습니다.
주요 발견:
- ABRYSVO는 이전 연구와 일치하는 안전성 프로필을 가지고 잘 견디는 것으로 나타났습니다.
- 120 µg의 단일 용량이 모든 집단과 연령대에서 RSV-A 및 RSV-B에 대한 강력한 중화 반응을 생성했습니다.
- 결과는 18-59세의 취약한 인구에서의 미충족 요구를 해결할 수 있는 ABRYSVO의 잠재력을 지원합니다.
화이자는 곧 다가오는 과학 회의에서 이러한 결과를 공유하고 규제 기관에 데이터를 제출할 계획입니다.
Pfizer (NYSE: PFE) a annoncé des résultats positifs de la sous-étude B de l'essai clinique MONeT de phase 3, évaluant le vaccin ABRYSVO chez des adultes immunodéprimés à risque de maladies graves des voies respiratoires inférieures associées au RSV. L'étude a impliqué 203 adultes répartis en quatre groupes : patients atteints d'un cancer du poumon non à petites cellules, patients sous hémodialyse, patients atteints de troubles auto-immuns sous thérapie immunomodulatrice et receveurs de greffes d'organes solides.
Résultats clés :
- ABRYSVO a été bien toléré avec un profil de sécurité cohérent avec les études précédentes
- Une seule dose de 120 µg a généré de fortes réponses neutralisantes contre RSV-A et RSV-B dans tous les groupes et tranches d'âge
- Les résultats soutiennent le potentiel d'ABRYSVO à répondre aux besoins non satisfaits dans des populations vulnérables âgées de 18 à 59 ans
Pfizer prévoit de partager ces résultats lors d'une prochaine conférence scientifique et de soumettre les données aux agences réglementaires pour examen.
Pfizer (NYSE: PFE) hat positive Ergebnisse aus der Substudie B der Phase-3-Studie MONeT veröffentlicht, die den Impfstoff ABRYSVO bei immunkompromittierten Erwachsenen untersucht, die ein Risiko für schwere RSV-assoziierte Erkrankungen der unteren Atemwege aufweisen. Die Studie umfasste 203 Erwachsene aus vier Gruppen: Patienten mit nicht-kleinzelligem Lungenkrebs, Hämodialyse-Patienten, Patienten mit Autoimmunerkrankungen, die eine immunmodulatorische Therapie erhalten, und Empfänger von festen Organtransplantaten.
Wichtige Ergebnisse:
- ABRYSVO wurde gut vertragen und wies ein Sicherheitsprofil auf, das mit früheren Studien übereinstimmt
- Eine einmalige Dosis von 120 µg erzielte in allen Kohorten und Altersgruppen starke neutralisierende Reaktionen gegen RSV-A und RSV-B
- Die Ergebnisse unterstützen das Potenzial von ABRYSVO, ungedeckte Bedürfnisse in verletzlichen Bevölkerungsgruppen im Alter von 18 bis 59 Jahren zu adressieren
Pfizer plant, diese Ergebnisse auf einer bevorstehenden wissenschaftlichen Konferenz zu teilen und die Daten den Regulierungsbehörden zur Überprüfung vorzulegen.
- ABRYSVO demonstrated a favorable safety profile in immunocompromised adults
- Single dose of ABRYSVO generated strong neutralizing responses against RSV-A and RSV-B
- Results support potential expansion of ABRYSVO's use to adults aged 18-59 with immunocompromising conditions
- FDA approved ACT-O-VIAL presentation of ABRYSVO, offering storage and workflow improvements
- None.
Insights
The top-line results from Pfizer's ABRYSVO® study in immunocompromised adults are highly significant. The vaccine's strong neutralizing response against both RSV-A and RSV-B subtypes after a single dose is particularly noteworthy. This could be a game-changer for high-risk populations, especially those aged 18-59 who currently lack approved RSV vaccines in the U.S.
The study's diverse cohort, including patients with cancer, renal disease, autoimmune disorders and organ transplants, provides a comprehensive view of the vaccine's potential. The consistent safety profile across different studies is reassuring. However, it's important to await peer-reviewed publication for a more detailed analysis of the data, particularly regarding any subgroup differences or long-term efficacy.
The FDA's approval of the ACT-O-VIAL® presentation is a practical enhancement, potentially improving vaccine distribution and administration efficiency. This could be particularly beneficial during peak RSV seasons.
Pfizer's positive results for ABRYSVO® in immunocompromised adults could significantly expand the vaccine's market potential. With no current RSV vaccines approved for the 18-59 age group in the U.S., Pfizer is positioning itself to capture a lucrative new market segment.
The ACT-O-VIAL® approval is also noteworthy. This innovation could provide Pfizer with a competitive edge in vaccine distribution and storage, potentially leading to increased market share and improved profit margins.
Investors should monitor upcoming scientific presentations and regulatory submissions, as these could be catalysts for stock movement. However, it's important to consider that vaccine revenues can be cyclical and subject to public health trends. The ultimate financial impact will depend on pricing, reimbursement and market adoption rates.
- First assessment from an RSV vaccine study in immunocompromised adults show ABRYSVO was well-tolerated and generated strong neutralizing responses after a single dose in adults ≥ 18 years of age
- These results add to the growing body of evidence indicating a single dose of ABRYSVO provides strong immune protection against outcomes caused by RSV
Adults with immunocompromising conditions have an increased risk of developing RSV-LRTD. Substudy B of the MONeT trial was conducted to assess the safety and immunogenicity of two doses of ABRYSVO, administered one month apart, in four groups of immunocompromised adults: those with non-small cell lung cancer, those on hemodialysis due to end-stage renal disease, those with autoimmune inflammatory disorder receiving active immunomodulator therapy, and solid organ transplant recipients. Of the 203 adults enrolled in the substudy, approximately half were between the ages of 18 to 59, and approximately half were 60 years or older.
ABRYSVO was well-tolerated during the trial, showing a safety profile consistent with findings from other studies of the vaccine. While the company evaluated two doses, a single 120 µg dose of ABRYSVO generated a strong neutralizing response against both subtypes of RSV, RSV-A and RSV-B, across all cohorts and age groups in the study. Pfizer plans to share these findings at an upcoming scientific conference and publish them in a peer-reviewed scientific journal, as well as submit these data to the regulatory agencies for review.
“Immunocompromised adults, such as patients with cancer or autoimmune disorders, have a substantially increased risk of experiencing severe complications from RSV, yet there are currently no vaccines approved for those aged 18 to 59 in the U.S.,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer. “We are encouraged by the positive top-line data from this study, which provide important evidence that ABRYSVO has the potential to address a significant unmet need in this vulnerable population.”
These most recent data in immunocompromised adults build on the body of evidence supporting the profile of ABRYSVO in high-risk adults. In June of 2024 at the meeting of the Advisory Committee on Immunization Practices (ACIP), Pfizer presented results from a cohort of adults aged 18-59 with certain chronic medical conditions. In the double-blinded study, 681 adults aged 18 to 59 with chronic conditions were randomized 2:1 to receive a single dose of ABRYSVO or placebo. Participants demonstrated RSV-A and RSV-B subgroup neutralizing responses non-inferior to the response seen in the Phase 3 (NCT05035212) RENOIR study of ABRYSVO, which previously demonstrated ABRYSVO’s efficacy in a population of adults aged 60 or older. These results support previous data presented at the ACIP showing high ABRYSVO clinical effectiveness against lower respiratory tract disease among a population of adults age 60 years and older that included a substantial proportion of immunocompromised persons.
Approval of ACT-O-VIAL®
Additionally and as previously announced, the
ABOUT MONeT
MONeT (RSV IMmunizatiON Study for AdulTs at Higher Risk of Severe Illness) is a Phase 3, multicenter clinical trial (NCT05842967) investigating the safety, tolerability and immunogenicity of ABRYSVO in adults at risk of RSV-associated disease, including adults with certain chronic medical conditions (substudy A) and adults who are immunocompromised (substudy B). Substudy A is a double-blinded study that randomized 681 adults aged 18 to 59 with chronic conditions, with 2:1 to receive a single dose of ABRYSVO or placebo. Substudy B is an open-label study that enrolled approximately 200 immunocompromised adults aged 18 or older, roughly half of which were aged 60 or older, who received two doses of ABRYSVO, one month apart.
ABOUT RSV
Respiratory syncytial virus (RSV) is a contagious virus and a common cause of respiratory illness.1 The virus can affect the lungs and breathing passages of an infected individual and can potentially cause severe illness in young infants, older adults, and individuals with certain chronic medical conditions.2,3,4 In
ABOUT ABRYSVO
Pfizer currently is the only company with an RSV vaccine to help protect older adults, as well as infants through maternal immunization. ABRYSVO is a bivalent vaccine that was designed to provide protection against RSV-LRTD, regardless of the virus subgroup. In the prefusion state, the RSV fusion protein (F) is a major target of neutralizing antibodies, serving as the basis of Pfizer’s RSV vaccine. Variations in the F protein sequence among RSV-A and RSV-B subgroups are clustered in a key antigenic site, a target for potent neutralizing antibodies.
In May 2023, the FDA approved ABRYSVO for the prevention of LRTD caused by RSV in individuals 60 years of age or older. The Advisory Committee on Immunization Practices (ACIP) of the
Also in August 2023, Pfizer announced that the European Medicines Agency (EMA) granted marketing authorization for ABRYSVO for both older adults and maternal immunization to help protect infants. The vaccine has also received approvals from la Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) of
In addition to MONeT, Pfizer has initiated a clinical trial evaluating ABRYSVO in children ages two to less than 18 years who are at higher risk for RSV disease.14
INDICATIONS FOR ABRYSVO
ABRYSVO™ is a vaccine indicated in the US for:
- the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in people 60 years of age and older
- pregnant individuals at 32 through 36 weeks gestational age for the prevention of LRTD and severe LRTD caused by RSV in infants from birth through 6 months of age
IMPORTANT SAFETY INFORMATION FOR ABRYSVO
- ABRYSVO should not be given to anyone with a history of severe allergic reaction (e.g., anaphylaxis) to any of its components
- For pregnant individuals: to avoid the potential risk of preterm birth, ABRYSVO should be given during 32 through 36 weeks gestational age
- Fainting can happen after getting injectable vaccines, including ABRYSVO. Precautions should be taken to avoid falling and injury during fainting
- Adults with weakened immune systems, including those receiving medicines that suppress the immune system, may have a reduced immune response to ABRYSVO
- Vaccination with ABRYSVO may not protect all people
-
In adults 60 years of age and older, the most common side effects (≥
10% ) were fatigue, headache, pain at the injection site, and muscle pain -
In pregnant individuals, the most common side effects (≥
10% ) were pain at the injection site, headache, muscle pain, and nausea, -
In clinical trials where ABRYSVO was compared to placebo, infants born to pregnant individuals experienced low birth weight (
5.1% ABRYSVO versus4.4% placebo) and jaundice (7.2% ABRYSVO versus6.7% placebo)
View the full ABRYSVO Prescribing Information.
About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
DISCLOSURE NOTICE:
The information contained in this release is as of August 12, 2024. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about ABRYSVO, including its potential benefits, plans to share findings from an RSV vaccine study in immunocompromised adults at an upcoming scientific conference and publish them in a peer-reviewed scientific journal, planned regulatory submissions, a potential new indication for ABRYSVO and clinical trials initiated for ABRYSVO in other populations, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of ABRYSVO; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with interim data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when biologic license applications may be filed in particular jurisdictions for ABRYSVO for any potential indications; whether and when any applications that may be pending or filed for ABRYSVO may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether ABRYSVO for any such indications will be commercially successful; intellectual property and other litigation; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of ABRYSVO; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities regarding ABRYSVO and uncertainties regarding the commercial impact of any such recommendations; uncertainties regarding the impact of COVID-19 on our business, operations and financial results; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the
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1 Centers for Disease Control and Prevention. Respiratory Syncytial Virus Infection (RSV). https://www.cdc.gov/rsv/index.html. Updated December 18, 2020.
2 Centers for Disease Control and Prevention. How RSV Spreads. https://www.cdc.gov/rsv/causes/index.html. Updated May 30, 2024.
3 Centers for Disease Control and Prevention. Respiratory Syncytial Virus Infection (RSV) – Older Adults are at High Risk for Severe RSV Infection Fact Sheet. https://www.cdc.gov/rsv/factsheet-older-adults.pdf. Updated April 2024.
4 Centers for Disease Control and Prevention. RSV in Infants and Young Children. https://www.cdc.gov/rsv/infants-young-children/index.html. Updated June 5, 2024.
5 Centers for Disease Control and Prevention. RSV Surveillance & Research. https://www.cdc.gov/rsv/php/surveillance/. Updated June 5, 2024.
6 Widmer K, Zhu Y, Williams JV, et al. Rates of Hospitalizations for Respiratory Syncytial Virus, Human Metapneumovirus, and Influenza Virus in Older Adults. J Infect Dis. 2012; 206(1):56-62.
7 Branche AR, Saiman L, Walsh EE, et al. Incidence of Respiratory Syncytial Virus Infection Among Hospitalized Adults, 2017–2020. CID. 2022;74(6):1004-1011.
8 McLaughlin JM, Khan F, Begier E, et al. Rates of Medically Attended RSV among US Adults: A Systematic Review and Meta-analysis. Open Forum Infect Dis. 2022; 9(7): ofac300.
9 Zheng Z, Warren JL, Shapiro ED, et al. Estimated Incidence of Respiratory Hospitalizations Attributable to RSV Infections across Age and Socioeconomic Groups. Pneumonia. 2022;14(1):6.
10 Centers for Disease Control and Prevention. October 2022 ACIP Meeting Slides. ACIP Adult RSV Work Group Considerations. Available at: https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2024-06-26-28/12-RSV-Adult-Melgar-508.pdf
11 Thompson WW, Shay DK, Weintraub E, et al. Mortality Associated with Influenza and Respiratory Syncytial Virus in
12 Matias G, Taylor R, Haguinet F, et al. Estimates of Mortality Attributable to Influenza and RSV in
13 Hansen CL, Chaves SS, Demont C, Viboud C. Mortality Associated With Influenza and Respiratory Syncytial Virus in the US, 1999-2018.JAMA Network Open. 2022 Feb 1;5(2):e220527.
14 Pfizer Second-Quarter 2023 Earnings Teleconference Presentation, August 1, 2023, page, 24, https://s28.q4cdn.com/781576035/files/doc_financials/2023/q2/Q2-2023-PFE-Earnings-Release.pdf
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