On May 25, 2023 Pfizer Inc. (NYSE: PFE) reported that it will present data across its Oncology portfolio and growing pipeline, covering multiple tumor types and novel mechanisms of action at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago from June 2 through June 6 (Press release, Pfizer, MAY 25, 2023, View Source [SID1234632120]). Abstracts include new data from pivotal trials supporting ongoing regulatory reviews for three potential therapies, if approved, and new clinical data for six early pipeline assets. In addition, Pfizer will highlight its ongoing scientific leadership in breast cancer with additional real-world evidence (RWE) for IBRANCE (palbociclib) and initial first-in-human results for its novel CDK4- and CDK2-selective inhibitors, respectively, and novel epigenetic modulator KAT6 inhibitor.

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"Forward-Looking Information and Factors That May Affect Future Results"

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"At ASCO (Free ASCO Whitepaper), Pfizer will present new data across the four key areas of our industry-leading portfolio – breast cancer, genitourinary cancer, hematology, and precision medicine – and for the first time, first-in-human data for some of our most exciting pipeline medicines," said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology and Rare Disease, Pfizer Global Product Development. "With four anticipated regulatory decisions this year and a growing portfolio of multiple mechanisms of action, Pfizer Oncology is poised to take our scientific innovation to the next level and bring new hope to people with cancer."

Today, Pfizer Oncology has a comprehensive portfolio of 24 approved innovative cancer medicines and biosimilars to treat more than 30 cancer types and an extensive pipeline of more than 30 programs in clinical development. With the recently announced proposed acquisition of Seagen*, a leader in antibody-drug conjugate technology, Pfizer is further accelerating its fight against cancer to deliver the next generation of Oncology breakthroughs.

"Placing patients at the center of everything we do is a critical component of advancing cutting-edge science and improving outcomes for patients," said Dany Habr, M.D., Oncology Chief Medical Affairs Officer, Pfizer. "At ASCO (Free ASCO Whitepaper), we look forward to connecting with the entire Oncology community to continue our efforts and shared approaches in making scientific breakthroughs accessible to all people living with cancer, everywhere."

Pfizer’s commitment to advancing scientific innovation will be on display at ASCO (Free ASCO Whitepaper) 2023 with more than 40 company-sponsored abstracts. Highlights include:

13 abstracts across the comprehensive MagnetisMM clinical trial program reinforcing the efficacy and safety of elranatamab, an investigational subcutaneous B-cell maturation antigen (BCMA)-CD3-targeted bispecific antibody, in relapsed or refractory multiple myeloma (RRMM), including an oral presentation on the first data from patients treated with prior BCMA-targeted therapy. Elranatamab is under Priority Review with the U.S. Food and Drug Administration (FDA) and under review with the European Medicines Agency (EMA) for the treatment of RRMM.
Four abstracts, including an oral presentation on new additional data from the Phase 3 TALAPRO-2 study, supporting the potential of TALZENNA (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor that plays a role in DNA damage repair, in combination with XTANDI (enzalutamide), an androgen receptor signaling inhibitor, in men with metastatic castration-resistant prostate cancer. The FDA has granted Priority Review for the Supplemental New Drug Application (sNDA) for TALZENNA in combination with XTANDI and an application is also under review with the EMA.
For the first time, the primary efficacy and safety results from the Phase 2 PHAROS trial exploring BRAFTOVI (encorafenib), an oral BRAF kinase inhibitor, given in combination with MEKTOVI (binimetinib), an oral MEK inhibitor, in patients with metastatic non-small cell lung cancer harboring a BRAF V600E mutation.** Results from the PHAROS study support the sNDAs for BRAFTOVI and MEKTOVI in this setting that are currently under review by the FDA.
Advancements across Pfizer’s leading breast cancer portfolio and pipeline, including a new analysis of real-world evidence for IBRANCE, an oral first-in-class inhibitor of cyclin-dependent kinases (CDKs) 4 and 6, as a first-line treatment of metastatic breast cancer. In addition, the first Phase 1 data for the CDK4-selective inhibitor PF-07220060, the CDK2-selective inhibitor PF-07104091 and the KAT6 inhibitor PF-07248144, all investigational agents for advanced or metastatic hormone-receptor positive breast cancer, will be presented.

A complete list of Pfizer-sponsored accepted abstracts is available at View Source

Pfizer is also 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 May 25.

Key Pfizer-sponsored oral and poster discussion presentations at ASCO (Free ASCO Whitepaper) 2023 include:

BREAST CANCER

Poster Discussion (Abstract 3009)

Saturday, June 3, 1:15-2:45 PM CDT

First-in-human first-in-class Phase 1/2a study of the next generation CDK4-selective inhibitor PF-07220060 in patients (pts) with advanced solid tumors, enriched for HR+ HER2- mBC pts who progressed on prior CDK4/6 inhibitors and endocrine therapy.

Yap TA

Poster Discussion (Abstract 3010)

Saturday, June 3, 1:15-2:45 PM CDT

First-in-human Phase 1/2a study of a potent and novel CDK2-selective inhibitor PF-07104091 in patients (pts) with advanced solid tumors, enriched for CDK4/6 inhibitor resistant HR+/HER2- breast cancer pts.

Yap TA

Poster Discussion (Abstract 1018)

Sunday, June 4, 11:30 AM-1:00 PM CDT

First-line systemic treatment with palbociclib in women aged ≥70 years presenting with hormone receptors-positive advanced breast cancer: Results from the PALOMAGE program.

Carola E

GENITOURINARY CANCERS

Oral Presentation (Abstract 5004)

Sunday, June 4, 8:00-11:00 AM CDT

TALAPRO-2: Phase 3 study of talazoparib (TALA) + enzalutamide (ENZA) versus placebo (PBO) + ENZA as first-line (1L) treatment for patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) harboring homologous recombination repair (HRR) gene alterations.

Agarwal N

Poster Discussion (Abstract 5013)

Saturday, June 3, 1:15-2:45 PM CDT

Patient-reported outcomes (PROs) among men receiving talazoparib (TALA) + enzalutamide (ENZA) vs placebo (PBO) + ENZA as first-line (1L) treatment for metastatic castration-resistant prostate cancer (mCRPC): Results from a phase 3 study (TALAPRO-2).

Agarwal N

Poster Discussion (Abstract 4515)

Saturday, June 3, 3:00-4:30 PM CDT

Estimated net benefit of avelumab (AVE) + best supportive care (BSC) vs BSC alone for patients (pts) with advanced urothelial carcinoma (aUC) using a quality-adjusted time without cancer symptoms or toxicity (Q-TWiST) analysis.

Powles T

Poster Discussion (Abstract 4516)

Saturday, June 3, 3:00-4:30 PM CDT

Long-term safety of avelumab first-line (1L) maintenance for advanced urothelial carcinoma (aUC) in the JAVELIN Bladder 100 trial.

Bellmunt J

HEMATOLOGY

Oral Presentation (Abstract 8008)

Saturday, June 3, 1:15-4:15 PM CDT

Efficacy and safety of elranatamab in patients with relapsed/refractory multiple myeloma (RRMM) and prior B-cell maturation antigen (BCMA)-directed therapies: A pooled analysis from MagnetisMM studies.

Nooka AK

PRECISION MEDICINE

Poster Discussion (Abstract 9018)

Sunday, June 4, 4:30-6:00 PM CDT

Efficacy and safety of encorafenib (enco) plus binimetinib (bini) in patients with BRAF V600E-mutant (BRAFV600E) metastatic non-small cell lung cancer (NSCLC) from the phase 2 PHAROS study.

Riely G

Other/Advanced Cancers

Oral Presentation (Abstract 11508)

Monday, June 5, 11:30 AM-2:30 PM CDT

Safety and clinical activity of TTI-621 in combination with doxorubicin in patients with unresectable or metastatic high-grade leiomyosarcoma: Results from the low-dose expansion cohort.

Movva S

Poster Discussion (Abstract 3020)

Saturday, June 3, 1:15-2:45 PM CDT

A first-in-human, phase 1 study of the SHP2 inhibitor PF-07284892 as monotherapy and in combination with different targeted therapies in oncogene-driven treatment-resistant solid tumors.

Drilon A