axelvento
2 일 전
TALZENNA + XTANDI is the first PARP inhibitor plus ARPI combination to demonstrate statistically significant and clinically meaningful improvement in overall survival (OS) in patients with metastatic castration-resistant prostate cancer (mCRPC) regardless of HRR mutation status
TALZENNA + XTANDI improved median OS by almost 9 months in unselected patients (Cohort 1) and by 14 months in patients selected for HRR mutations (Cohort 2) versus standard of care XTANDI
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) today announced positive results from the Phase 3 TALAPRO-2 study of TALZENNA® (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI® (enzalutamide), an androgen receptor pathway inhibitor (ARPI), demonstrating a statistically significant and clinically meaningful improvement in overall survival (OS) compared to placebo plus XTANDI in patients with metastatic castration-resistant prostate cancer (mCRPC), with or without homologous recombination repair (HRR) gene mutations. The TALAPRO-2 results will be presented at the American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium in San Francisco and featured in the ASCO GU official Press Program.
The TALAPRO-2 study evaluated two sets of patients, unselected (cohort 1) and selected for HRR gene-mutations (cohort 2). Overall survival was a prespecified, alpha-protected key secondary endpoint. After more than four years of median follow-up (52.5 months), the median OS in cohort 1 was 45.8 months with TALZENNA in combination with XTANDI, and 37.0 months with XTANDI and placebo (Hazard Ratio [HR] of 0.80; 95% Confidence Interval [CI], 0.66-0.96; p=0.015), representing a 20% reduction in the risk of death. This represents a nearly 9-month gain in median OS versus standard of care XTANDI. Data from cohort 1 will be presented today at ASCO GU in an oral presentation (Abstract LBA18) by Dr. Neeraj Agarwal, global lead investigator for TALAPRO-2.
In Cohort 2, a statistically significant and clinically meaningful improvement in OS was observed in patients with HRR-mutated mCRPC. At a median follow-up of 44.2 months, the median OS was 45.1 months with TALZENNA in combination with XTANDI, and 31.1 months with XTANDI and placebo (HR of 0.62; 95% CI, 0.48-0.81; p=0.0005), a 38% reduction in the risk of death. This result represents a 14-month gain in median OS versus standard of care XTANDI in a patient population with a historically poor prognosis. The OS improvement in the HRR-mutated population was observed in patients in both BRCA and non-BRCA gene alterations. Dr. Karim Fizazi, Institut Gustave Roussy, University of Paris-Saclay will share data from Cohort 2 at ASCO GU today (Abstract LBA141).
“Since its approval, TALZENNA in combination with XTANDI has redefined the standard of care for those living with homologous recombination repair gene-mutated mCRPC. These latest data from TALAPRO-2 are extremely compelling, demonstrating that the combination significantly extended overall survival, in patients selected and unselected for HRR gene alterations, potentially shifting the treatment paradigm for all men living with mCRPC,” said Roger Dansey, M.D., Chief Oncology Officer, Pfizer. “Although definitive conclusions cannot be drawn across studies, these results appear to represent the longest median overall survival reported in a randomized, controlled Phase 3 trial in mCRPC. We look forward to continuing to work with global authorities to potentially update the TALZENNA label with these results.”
“TALAPRO-2 is the first study demonstrating a significant and clinically meaningful survival benefit using a combination of PARP and androgen receptor inhibitors in mCRPC,” said Neeraj Agarwal, M.D., FASCO, Professor and Presidential Endowed Chair of Cancer Research at Huntsman Cancer Institute, University of Utah, and global lead investigator for TALAPRO-2. “Survival rates in metastatic castration-resistant prostate cancer are poor due to the advanced and aggressive stage of the disease. Today’s results demonstrate the potential for TALZENNA in combination with XTANDI to be a practice-changing treatment to help improve patient survival in mCRPC.”
At the time of the final analysis, updated radiographic progression free survival (rPFS) and other secondary efficacy endpoints demonstrated maintained clinical benefit in both cohorts and were consistent with the primary analyses previously reported and published in The Lancet and Nature Medicine.
In addition to the FDA, these data have been shared with the European Medicines Agency (EMA) and other global health authorities to support potential updates of the approved labels for TALZENNA.
The safety profile of TALZENNA plus XTANDI was generally consistent with the known safety profile of each medicine. The most common all-cause adverse events in the TALZENNA group (=30% of patients) were anemia, neutropenia, and fatigue, and the most common (=10% of patients) grade 3–4 adverse events were anemia (49%) and neutropenia (19.3%). Adverse events were generally manageable with dose modification and supportive care.
https://www.biospace.com/press-releases/pfizers-talzenna-in-combination-with-xtandi-improves-survival-outcomes-in-metastatic-castration-resistant-prostate-cancer
axelvento
4 일 전
A paper inadvertently published on the website of an ASCO conference revealed good results for mevrometostat in treating castration-resistant prostate cancer.
Pfizer’s experimental drug mevrometostat cut disease progression rates in half in combination with standard hormone therapy, according to an article describing data from a Phase I trial of metastatic castration-resistant prostate cancer that appeared on Monday morning on the website for the ASCO Genitourinary Cancers Symposium.
The only issue is that the team from Pfizer wasn’t going to speak about the data until Thursday. Later in the day Monday, the conference published a full study abstract.
In addition to reducing disease progression rates, mevrometostat cut the risk of death by 49% in trial participants, all of whom had already received hormone treatment and one round of chemotherapy, according to reporting from Endpoints News.
Adverse effects were diarrhea (78% of patients), decreased appetite (58.5%) and dysgeusia (58.5%).
Pfizer is currently recruiting for two Phase III trials, MEVPRO-1 and MEVPRO-2, testing mevrometostat, an inhibitor of the oncoprotein EZH2, in prostate cancer as well.
Castration-resistant prostate cancer is a common form of prostate cancer, often treated with androgen deprivation therapy and chemotherapy.
The results, although announced prematurely, should be welcome news for Pfizer. Analysts were already buoyant on the company, with Guggenheim analysts writing in an investor note early Monday morning, before the leak, that Pfizer beat their fourth quarter 2024 expectations as well as consensus estimates.
Pfizer has a number of critical updates from its oncology pipeline coming down the pike this year. Phase III data for vepdegestrant in treating breast cancer and danuglipron for obesity are expected later this quarter, as well as Padcev in combination with pembrolizumab for bladder cancer sometime this year. On Monday, Pfizer announced data showing that Padcev in combination with Merck’s Keytruda reduced the risk of death by 49% in urothelial cancer compared to chemotherapy.
https://www.biospace.com/drug-development/leaked-conference-article-shows-pfizers-positive-phase-i-prostate-cancer-data
https://meetings.asco.org/abstracts-presentations/243221
DewDiligence
2 주 전
PFE reports 4Q24 results—reiterates 2025 guidance:
https://s28.q4cdn.com/781576035/files/doc_financials/2024/q4/Q4-2024-PFE-Earnings-Release-Final.pdf
4Q24 highlights
• 4Q24 revenue was $17.8B, +21% YoY. After adjusting for the 4Q23 Paxlovid writedown, 4Q24 revenue was +11% YoY.
• 4Q24 oncology sales were $4.1B, +27% YoY, including a $915M contribution from legacy Seagen products.
• 4Q24 Comirnaty and Paxlovid sales were $3.4B (-62% YoY) and $727M (no meaningful growth rate due to 4Q23 writedown), respectively.
• 4Q24 Abrysvo sales were $198M, -62% YoY; however, Abrysvo sales in the maternal indication increased sharply.
• 4Q24 GAAP and non-GAAP EPS were $0.07 and $0.63, respectively. The GAAP figure includes a $2.9B non-cash asset-impairment writedown relating to various products.
2025 guidance for revenue and non-GAAP remains as announced in December (#msg-175541136).
4Q24 CC slides:
https://s28.q4cdn.com/781576035/files/doc_financials/2024/q4/Q4-2024-Earnings-Charts-FINAL.pdf
4Q24 CC prepared remarks (synched with slides): https://s28.q4cdn.com/781576035/files/doc_financials/2024/q4/Q4-2024-Earnings-Conference-Call-Prepared-Remarks-FINAL.pdf
axelvento
2 주 전
Pfizer Inc. will present the latest results from its leading genitourinary (GU) portfolio at the American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium taking place February 13-15 in San Francisco, California. Data from more than 20 company-sponsored, investigator-sponsored, and collaborative research abstracts, including five oral presentations, highlight advancements in developing new standards of care within prostate and bladder cancer across the company’s core scientific modalities, including small molecules and antibody-drug conjugates.
https://www.stocktitan.net/news/PFE/pfizer-to-showcase-advancements-across-genitourinary-cancers-at-asco-4m71mveugfbl.html