Mevrometostat

Pfizer’s internal calculation suggests that “on paper” more than eight cancer drugs could become blockbusters, even though the company is only publicly targeting eight for now, Suneet Varma, Pfizer Oncology’s commercial president, said. During a recent investor event dedicated to the newly expanded oncology business, Pfizer unveiled a goal to have eight blockbuster cancer drugs by 2030 but fell short of naming specific products. That contribution of blockbusters will come from each of Pfizer Oncology’s four focused therapeutic areas, Suneet Varma, the division’s commercial president, told Fierce Pharma in an interview on the sidelines of American Society of Clinical Oncology annual meeting in Chicago. The four fields are breast, genitourinary, hematology and thoracic cancers. Pfizer’s internal calculation suggests that “on paper” more than eight cancer drugs could become blockbusters, but the New York pharma decided that eight is what it can stand by now, Varma added. Pfizer is betting big on oncology with the $43 billion acquisition of antibody-drug conjugate specialist Seagen last year. The heavy investment runs in parallel with some multiyear, multi-billion-dollar cost-cutting schemes as once high-flying sales from COVID products fell back to earth. Like many Big Pharma deals, the Seagen tie up came with its own consolidation, including a round of proposed layoffs in Switzerland and scrapping of a manufacturing facility in Washington. The oncology department won’t be affected by Pfizer’s latest multiyear cost reduction, or, as Varma put it: “there’s nothing more to be done in oncology.” The unit has already finished its organizational shuffles and cost containment efforts, including as part of the integration between Pfizer and Seagen, he said. Pfizer in December made oncology a separate division within the group and named then-oncology R&D head Chris Boshoff, M.D., Ph.D., as chief oncology officer. As to whether Pfizer Oncology might expand its commercial infrastructure further, Varma said, “We’re at the scale that we think we need to be.”   Lung cancer reaching 'critical mass' Among the four focus areas, thoracic cancer, or mainly lung cancer, is currently the weakest link in Pfizer’s portfolio. But Varma argued that “lung will become its own franchise when it has that sufficient critical mass, which I think is upon us.” At the ASCO meeting a few days ago, Pfizer unveiled updated phase 3 results for the next-generation ALK inhibitor Lorbrena in newly diagnosed advanced ALK-positive non-small cell lung cancer. After five years, 60% of patients who got Lorbrena in the CROWN trial remained alive without disease progression, compared with just 8% for those who got Pfizer’s old ALK drug Xalkori. By investigators’ analysis, Lorbrena led to an 81% reduction in the risk of disease progression or death, or a 94% reduction in progression of brain metastases, over Xalkori. The progression-free survival results were compelling, and they compare well across trials with Roche’s current first-line standard of care, Alecensa, which reported a five-year overall survival rate of 62.5% in a phase 3 Xalkori head-to-head trial, Leerink Partners analysts said in a May 31 note.   Since its first-line approval in March 2021, Lorbrena hasn’t really threatened Alecensa’s leading position in the ALK space. In 2023, Alecensa brought Roche 1.5 billion ($1.7 billion) Swiss francs in sales, while Lorbrena ginned up $539 million for Pfizer. An FDA approval in April also just moved Alecensa into postsurgical treatment of early-stage cancers, whereas Pfizer currently doesn’t have any studies geared toward that indication. One problem that has stopped more doctors from using Lorbrena in the first-line setting has to do with the drug’s neuro toxicities, including such side effects as seizures, changes in cognitive functions or mood, mental status, among others.  Lorbrena’s best-in-class tumor progression results could persuade some doctors and patients to use it upfront, “although we do not expect it to rapidly become standard of care given the toxicity and tolerability profile, especially with no approved drugs to treat patients failing [Lorbrena],” the Leerink analysts noted. But Varma said Pfizer remains “very bullish” on Lorbrena. “Yes, there’s extra therapy management required,” Varma acknowledged. “But it’s worth it because years of life are being added to the patients.” “When we look at the data of people who switched [to Lorbrena], the outcomes are not as good,” Varma said. “So we believe firmly in your first chance is your best chance with Lorbrena.” Pfizer is applying to Lobrena some therapy management know-how brought over by the Seagen team, Varma noted. ADCs often come with complex side-effect profiles, and Seagen’s advice there could be helpful.   Genitourinary franchise to surpass breast cancer portfolio The addition of Seagen and its ADC portfolio also allows Pfizer to expand commercial capabilities in biologics as the pharma giant’s cancer portfolio has historically been dominated by small molecules. The Pfizer-Seagen cross-boosting goes in both ways, Varma said. Pfizer has its large scale and sophistication in commercialization. Pfizer Oncology’s commercial and medical sales team was already double the size of Seagen’s before the combination, and the large pharma company is now applying its digital and publicist tools to all Seagen products. Legacy Seagen’s Astellas-partnered bladder cancer drug Padcev is among the top 10 brands that Pfizer Oncology is granting “disproportionate attention” for investment and resources, sales force prioritization and agency assistance, Varma said. Thanks to some impressive first-line bladder cancer data in a combination with Merck & Co.’s Keytruda, Padcev has swept the oncology community off its feet. And Pfizer has put the Nectin-4 ADC’s peak sales at more than $3 billion from around $700 million last year, Varma said. The Pfizer exec has divided up the genitourinary cancer team into two franchises reporting directly to him: one for prostate cancer that’s built around Astellas-partnered blockbuster drug Xtandi, and the other for bladder and kidney cancers. “By separating prostate from bladder and having two GU teams, they get tremendous focus,” Varma said. Because of Padcev’s great commercial prospect, Pfizer sees GU as becoming the oncology unit’s largest franchise supplanting breast cancer between now and 2030 despite Xtandi’s expected U.S. patent cliff in 2027. Besides Padcev and Xtandi, Pfizer also has the PARP inhibitor Talzenna, which is approved alongside Xtandi in certain prostate cancer patients. In the pipeline, the company has the EZH2 inhibitor mevrometostat, which is being moved into phase 3 trials in prostate cancer; and the subcutaneous PD-1 inhibitor sasanlimab, which is initially being angled toward bladder cancer. In addition, the HER2 ADC, disitamab vedotin, also has FDA breakthrough therapy designation in HER2-positive advanced bladder cancer. As to breast cancer, the fall of Pfizer’s largest oncology asset, Ibrance, is already on full display ahead of a 2027 patent cliff. Sales from the CDK4/6 inhibitor dropped 7% year over year in 2023 to $4.75 billion as the first-in-class med faces intense competition from rival drugs by Novartis and Eli Lilly. Still, Varma suggested that Ibrance has reached “stabilization.” The aging product for now owns about half of the CDK4/6 market share and about a third of new patient starts, he said. Ibrance still plays a “foundational role” that allows other Pfizer franchises to grow and launch, Varma said. But he declined to offer a projection on where and when Ibrance might eventually bottom out. Down the pipeline, Pfizer has highlighted the selective CDK4 inhibitor atirmociclib, which it believes could become a next-generation backbone in HR-positive breast cancer. There’s also vepdegestrant, an estrogen receptor protein degrader. What’s more, disitamab vedotin could have a place behind AstraZeneca and Daiichi Sankyo’s much-touted ADC Enhertu in the HER2 breast cancer space. And Seagen’s former CEO David Epstein has touted that Enhertu-relapsed setting as a blockbuster opportunity as well.  Elsewhere in blood cancer, Pfizer is going toe-to-toe with Johnson & Johnson with their BCMA-directed T-cell engager for multiple myeloma. As J&J’s myeloma franchise is unrivaled for its modality breadth and commercial scale, Pfizer will face a tough fight even for a company of its size. Varma suggested that J&J’s franchise effect in myeloma won’t stop doctors from using Pfizer’s Elrexfio. And Seagen is here to help again, as Takeda-partnered Hodgkin lymphoma ADC Adcetris was the Seattle biotech’s biggest product before the merger. Despite his expressed confidence in Pfizer’s ability to reach eight cancer blockbusters by 2030, Varma again wouldn’t specify which drugs could reach that threshold. In a March note, Guggenheim analysts figured Padcev, Elrexfio, atirmociclib, vepdegestrant, mevrometostat, disitamab vedotin and sigvotatug vedotin (IB6 ADC) could make the cut.

More than 50 abstracts, including 11 oral presentations, span Pfizer’s robust portfolio of approved and pipeline therapies across its key tumor areas and core scientific modalities New five-year progression-free survival data for LORBRENA® (lorlatinib) in first-line ALK-positive advanced lung cancer Results from ECHELON-3, third Phase 3 study to demonstrate overall survival benefit for ADCETRIS® (brentuximab vedotin) in a type of lymphoma NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) highlights its progress in advancing new potential standards of care in Oncology at the 2024 American Society of Clinical Oncology (ASCO®) Annual Meeting, taking place May 31 to June 4 in Chicago. More than 50 abstracts, including 11 oral presentations, will be presented from Pfizer’s broadened portfolio of approved and pipeline therapies across the company’s key tumor areas and core scientific modalities, including small molecules, antibody-drug conjugates (ADCs) and bispecific antibodies. “We are excited to participate in our first ASCO Annual Meeting following the creation of Pfizer’s new Oncology organization, where we will highlight our efforts to accelerate breakthrough medicines that help people with cancer live better and longer lives,” said Chris Boshoff, Chief Oncology Officer and Executive Vice President, Pfizer. “We are looking forward to key data presentations across our newly expanded portfolio, including additional evidence reinforcing the benefit of several approved medicines and promising new data from our deep and diverse pipeline.” Key research includes an oral presentation of new five-year progression-free survival (PFS) results from the Phase 3 CROWN study of LORBRENA® (lorlatinib) in previously untreated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC), which will also be featured in ASCO’s embargoed pre-meeting press briefing on Wednesday, May 29. Additionally, results from the Phase 3 ECHELON-3 study of ADCETRIS® (brentuximab vedotin) in combination with lenalidomide and rituximab in relapsed/refractory diffuse large B-cell lymphoma (DLBCL) will be presented for the first time in an oral late-breaking session. Pfizer will also present Phase 1 data for several priority pipeline therapies, including oral presentations with updated results for sigvotatug vedotin (B6A; integrin beta-6 [IB6]-directed ADC) in NSCLC and data for PF-07248144, a potential first-in-class KAT6 inhibitor, in hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (mBC). “At ASCO, Pfizer will share important data highlighting the long-term impact of our medicines for patients, including five-year follow-up from the LORBRENA CROWN study, as well as the third Phase 3 study to demonstrate overall survival benefit for ADCETRIS in a type of lymphoma – in this case, relapsed/refractory diffuse large B-cell lymphoma,” said Karin Tollefson, Chief Oncology Medical Officer, Pfizer. “We are also looking forward to sharing updated results from our pipeline, where we now have over 50 programs in development and are rapidly advancing 20 ongoing pivotal trials across our key tumor types.” Key ASCO Presentations Pfizer will present data across its four tumor areas of focus at ASCO: breast cancer, genitourinary cancer, hematology-oncology and thoracic cancers, which includes lung cancer. Breast Cancer In breast cancer, Pfizer will present data for two next-generation pipeline medicines for HR+/HER2- mBC: updated Phase 1/2a safety data for atirmociclib, a potential best-in-class, highly selective cyclin-dependent kinase 4 (CDK4) inhibitor currently in Phase 3 development, and an oral presentation featuring Phase 1 data for PF-07248144, a potential first-in-class KAT6 inhibitor. Additionally, data for TUKYSA® (tucatinib) demonstrate its activity in previously treated HER2-mutated mBC, and new real-world evidence continues to support the value of IBRANCE® (palbociclib) in HR+/HER2- mBC, including from HENRI-3, a SEER-Medicare analysis evaluating overall survival (OS) with IBRANCE plus an aromatase inhibitor (AI) versus AI alone. Genitourinary Cancer Highlights from Pfizer’s genitourinary cancer portfolio will include updated data that continue to reinforce the potential of several recent priority launches, including PADCEV® (enfortumab vedotin-ejfv) in combination with KEYTRUDA® (pembrolizumab) in locally advanced/metastatic urothelial cancer,* XTANDI® (enzalutamide) in non-metastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high-risk for metastasis,** and TALZENNA® (talazoparib) in combination with XTANDI in metastatic castration-resistant prostate cancer (mCRPC) with homologous recombination repair (HRR) mutations. Additionally, updated Phase 1 data will be presented for the investigational enhancer of zeste homolog 2 (EZH2) inhibitor mevrometostat in combination with XTANDI in mCRPC; Pfizer anticipates initiating Phase 3 studies for this combination later this year. Hematology-Oncology In addition to the ECHELON-3 OS results for ADCETRIS in relapsed/refractory DLBCL, Pfizer will present seven-year OS results for ADCETRIS in advanced classical Hodgkin lymphoma,*** as well as new clinical and pharmacokinetic data with alternative dosing regimens for ELREXFIO™ (elranatamab-bcmm) in relapsed/refractory multiple myeloma from the MagnetisMM-9 trial. Thoracic Cancer In its thoracic portfolio, in addition to the LORBRENA CROWN results, Pfizer will present updated Phase 1 data for sigvotatug vedotin in advanced NSCLC, a promising investigational ADC that recently initiated a Phase 3 study. Additional Tumor Types An oral presentation on extended duration of response from the Phase 3 MOUNTAINEER trial adds to the positive pro TUKYSA in colorectal cancer. In addition, data will be presented from the innovaTV 301 trial of TIVDAK® (tisotumab vedotin-tftv), for which a supplemental Biologics License Application for the treatment of previously treated recurrent or metastatic cervical cancer was granted priority review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act date of May 9, 2024.**** Additional information on key Pfizer-sponsored abstracts, including date and time of presentation, follow in the chart below. A complete list of Pfizer-sponsored accepted abstracts is available here. Pfizer is continuing its commitment to help non-scientists understand the latest findings with the development of abstract plain language summaries (APLS) for company-sponsored research being presented at ASCO, which are written in non-technical language. Those interested in learning more can visit to access the summaries starting Friday, May 24. BREAST CANCER Oral Presentation (Abstract 3006) Saturday, June 1, 3:00-6:00 PM CDT A phase 1 dose expansion study of a first-in-class KAT6 inhibitor — (PF-07248144) in patients with advanced or metastatic ER+ HER2− breast cancer Mukohara et al Poster Presentation (Abstract 3108) Saturday, June 1, 9:00 AM-12:00 PM CDT First-in-human phase 1/2a study of the first-in-class, next-generation CDK4-selective inhibitor PF-07220060 + endocrine therapy (ET): Updated safety data in patients with HR+/HER2− mBC Giordano et al Poster Presentation (Abstract 1111) Sunday, June 2, 9:00 AM-12:00 PM CDT Overall survival with palbociclib (PAL) plus an aromatase inhibitor (AI) versus AI alone in older patients (pts) with de novo, HR+/HER2− metastatic breast cancer: A SEER-Medicare analysis Brufsky et al Poster Presentation (Abstract 1105) Sunday, June 2, 9:00 AM-12:00 PM CDT Tucatinib and trastuzumab for previously treated HER2-mutated metastatic breast cancer (SGNTUC-019): A phase 2 basket study Okines et al GENITOURINARY CANCER Oral Presentation (Abstract 4502) Monday, June 3, 8:00-11:00 AM CDT Patient-reported outcomes (PROs) from a randomized, phase 3 trial of enfortumab vedotin plus pembrolizumab (EV+P) versus platinum-based chemotherapy (PBC) in previously untreated locally advanced or metastatic urothelial cancer (la/mUC) Gupta et al Oral Presentation (Abstract 4503) Monday, June 3, 8:00-11:00 AM CDT Impact of exposure on outcomes with enfortumab vedotin in patients with locally advanced or metastatic urothelial cancer Petrylak et al Oral Presentation (Abstract 5005) Saturday, June 1, 3:00-6:00 PM CDT EMBARK post-hoc analysis of impact of treatment suspension (TxS) on health-related quality of life (HRQoL) Freedland et al Poster Presentation (Abstract 5021) Sunday, June 2, 9:00 AM-12:00 PM CDT Discovery of a novel non-negative matrix factorization (NMF)-based homologous recombination deficiency (HRD) score and subsequent exploration in TALAPRO-2 (TP-2), a phase 3 study of talazoparib (TALA) + enzalutamide (ENZA) vs placebo (PBO) + ENZA as first-line treatment in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) Fizazi et al Poster Presentation (Abstract 5061) Sunday, June 2, 9:00 AM-12:00 PM CDT Phase 1 trial of mevrometostat (PF-06821497), a potent and selective inhibitor of enhancer of zeste homolog 2 (EZH2), in castration-resistant prostate cancer (CRPC) Schweizer et al Poster Presentation (Abstract 5063) Sunday, June 2, 9:00 AM-12:00 PM CDT Matching-adjusted indirect comparisons (MAICs) of talazoparib plus enzalutamide (TALA+ENZA) versus olaparib plus abiraterone and prednisone/prednisolone (OLAP+AAP) for first-line (1L) therapy in patients with metastatic castration-resistant prostate cancer (mCRPC) and homologous recombination repair mutations (HRRm)/BRCAm Castro et al Poster Presentation (Abstract 4562) Sunday, June 2, 9:00 AM-12:00 PM CDT Enfortumab vedotin (EV) with pembrolizumab (P) versus chemotherapy (chemo) in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC): Analysis of cisplatin (cis)-eligible population from EV-302/KEYNOTE-A39 Bedke et al Poster Presentation (Abstract 4563) Sunday, June 2, 9:00 AM-12:00 PM CDT Enfortumab vedotin (EV) with pembrolizumab (P) versus chemotherapy (chemo) in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC): Analysis of the cisplatin (cis)-ineligible population from EV-302/KEYNOTE-A39 Van Der Heijden et al HEMATOLOGY-ONCOLOGY Oral Presentation (Abstract LBA7005) Saturday, June 1, 3:00-6:00 PM CDT Brentuximab vedotin in combination with lenalidomide and rituximab in patients with relapsed/refractory diffuse large B-cell lymphoma: Results from the phase 3 ECHELON-3 study Kim et al Poster Presentation (Abstract 7053) Monday, June 3, 9:00 AM-12:00 PM CDT Seven-year overall survival analysis from ECHELON-1 study of A+AVD versus ABVD in patients with previously untreated stage III/IV classical Hodgkin lymphoma Ansell et al Poster Presentation (Abstract 7522) Monday, June 3, 9:00 AM-12:00 PM CDT Evaluation of cytokine release syndrome (CRS) in patients with relapsed or refractory multiple myeloma (RRMM) receiving step-up priming doses and longer dosing intervals of elranatamab: MagnetisMM-9 Sborov D THORACIC CANCER Oral Presentation (Abstract LBA8503) Friday, May 31, 2:45-5:45 PM CDT Lorlatinib vs crizotinib in treatment-naïve patients with advanced ALK+ non-small cell lung cancer: 5-year progression-free survival and safety from the CROWN study Solomon et al Rapid Oral Presentation (Abstract 8521) Saturday, June 1, 4:30-6:00 PM CDT Efficacy and safety of sigvotatug vedotin, an investigational ADC, in NSCLC: Updated phase 1 results (SGNB6A-001) Peters et al GYNECOLOGICAL CANCER Poster Presentation (Abstract 5531) Monday, June 3, 9:00 AM-12:00 PM CDT Tisotumab vedotin in 2L/3L recurrent or metastatic cervical cancer: subsequent therapy data from ENGOT-cx12/GOG-3057/innovaTV 301 Manso Sánchez et al GASTROINTESTINAL CANCER Oral Presentation (Abstract 3509) Monday, June 3, 1:15-2:45 PM CDT Final results of a phase 2 study of tucatinib and trastuzumab for HER2-positive mCRC (MOUNTAINEER) Strickler et al *Pfizer and Astellas have a clinical collaboration agreement with Merck to evaluate the combination of PADCEV® and KEYTRUDA® in patients with previously untreated metastatic urothelial cancer. **XTANDI® is jointly developed and commercialized by Pfizer and Astellas in the United States. ***Pfizer and Takeda jointly develop ADCETRIS® on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs. Pfizer has U.S. and Canadian commercialization rights, and Takeda has rights to commercialize ADCETRIS® in the rest of the world. ****TIVDAK® is co-owned by Genmab and Pfizer, under an agreement in which the companies share costs and profits for the product on a 50:50 basis. Prescribing Information for Pfizer Medicines Please see full Prescribing Information, including BOXED WARNING, for ADCETRIS® (brentuximab vedotin). Please see full Prescribing Information, including BOXED WARNING, for ELREXFIOTM (elranatamab-bcmm). Please see full Prescribing Information for IBRANCE® (palbociclib) tablets and IBRANCE® (palbociclib) capsules. Please see full Prescribing Information for LORBRENA® (lorlatinib). Please see full Prescribing Information, including BOXED WARNING, for PADCEV® (enfortumab vedotin). Please see full Prescribing Information for TUKYSA® (tucatinib). Please see full Prescribing Information for TALZENNA® (talazoparib). Please see full Prescribing Information, including BOXED WARNING, for TIVDAK® (tisotumab vedotin-tftv). Please see full Prescribing Information for XTANDI® (enzalutamide). About Pfizer Oncology At Pfizer Oncology, we are at the forefront of a new era in cancer care. Our industry-leading portfolio and extensive pipeline includes three core mechanisms of action to attack cancer from multiple angles, including small molecules, antibody-drug conjugates (ADCs), and bispecific antibodies, including other immune-oncology biologics. We are focused on delivering transformative therapies in some of the world’s most common cancers, including breast cancer, genitourinary cancer, hematology-oncology, and thoracic cancers, which includes lung cancer. Driven by science, we are committed to accelerating breakthroughs to help people with cancer live better and longer lives. 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 more than 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 . 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