On April 29, 2024 Pfizer Inc. (NYSE: PFE) reported its progress in advancing new potential standards of care in Oncology at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 31 to June 4 in Chicago (Press release, Seagen, APR 29, 2024, View Source [SID1234642433]). 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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are excited to participate in our first ASCO (Free ASCO Whitepaper) 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 (Free ASCO Whitepaper)’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 (Free ASCO Whitepaper), 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 (Free ASCO Whitepaper) Presentations

Pfizer will present data across its four tumor areas of focus at ASCO (Free ASCO Whitepaper): 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 profile of 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 (Free ASCO Whitepaper), which are written in non-technical language. Those interested in learning more can visit www.Pfizer.com/apls 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).