Pfizer Announces Positive Topline Results from Phase 3 TALAPRO-2 Trial

  • TALZENNA® first PARP inhibitor to demonstrate clinical benefit in combination with XTANDI® in metastatic castration-resistant prostate cancer (mCRPC)
  • Study achieves primary endpoint of radiographic progression-free survival
  • Robust, highly consistent efficacy demonstrated in mCRPC both with or withouthomologous recombination repair gene mutations

PfizerInc.( NYSE PFE) moment blazoned positive topline results from the Phase 3 TALAPRO- 2 study of TALZENNA ®( talazoparib), an oral poly ADP- ribose polymerase( PARP) asset, in combination with XTANDI ®( enzalutamide) compared to placebo plus XTANDI in men with metastatic castration- resistant prostate cancer( mCRPC), with or without homologous recombination form( HRR) gene mutations. The study met its primary endpoint with a statistically significant and clinically meaningful enhancement in radiographic progression-free survival( rPFS) compared with placebo plus XTANDI. The results of the primary endpoint exceeded thepre-specified hazard rate of0.696.

Results showed a trend toward bettered overall survival, a crucial secondary endpoint, at the time of the analysis, but these data aren’t yet mature. Benefits were also observed in other secondary endpoints, including investigator assessed rPFS, prostate specific antigen( PSA) response, time to PSA progression, and overall response rate. Other secondary endpoints are being anatomized. At the time of topline analysis, the safety of TALZENNA plus XTANDI were generally harmonious with the given safety profile of each drug.
“ XTANDI is a global standard of care, with overall survival demonstrated in mCRPC,non-metastatic CRPC, and metastatic castration-sensitive prostate cancer( mCSPC), ” said Chris Boshoff,M.D.,Ph.D., Chief Development Officer, Oncology and Rare Disease, Pfizer Global Product Development. “ We’re veritably pleased with the strong findings from TALAPRO- 2, and although no definitive conclusions can be made across trials, the rPFS appears to be the longest observed in a randomized trial in this setting. These data punctuate the eventuality for TALZENNA in combination with XTANDI, if approved, to come a new standard of care for mCRPC, irrespective of HRR gene mutation status. We look forward to agitating these data with global health authorities. ”

“ These instigative results from TALAPRO- 2 emphasize our long-standing commitment to men living with prostate cancer and delivering the coming scientific improvements, ” said Suneet Varma, Global Oncology andU.S. President, Pfizer. “ Grounded on these compelling combination data with XTANDI, we believe TALZENNA in prostate cancer may come the coming implicit blockbuster occasion in our leading Pfizer Oncology portfolio, subject to nonsupervisory blessing. ”
Detailed results from TALAPRO- 2 will be submitted for donation at a near- term medical congress. These data will also be participated with global nonsupervisory authorities to potentially support a nonsupervisory form.

TALZENNA or the combination of TALZENNA plus XTANDI haven’t been approved by any nonsupervisory agency for the treatment of mCRPC. In addition to the TALAPRO- 2 trial, the combination of TALZENNA plus XTANDI is being delved in the TALAPRO- 3 trial( NCT04821622), a global, randomized, double-eyeless, placebo- controlled Phase 3 study in men with HRR-deficient mCSPC.
About Metastatic Castration- Resistant Prostate Cancer

Metastatic castration- resistant prostate cancer( mCRPC) is a cancer that has spread beyond the prostate gland and has progressed despite medical or surgical treatment to lower testosterone. roughly 10 – 20 of prostate cancer cases develop mCRPC within 5 −7 times of opinion, 1 and in theU.S., in 2020, roughly 60- 90 thousand cases of the three million prostate cancer cases were mCRPC.2
About TALAPRO- 2

The Phase 3 TALAPRO- 2 trial is a two- part, two- cohort, multicenter, randomized, double-eyeless, placebo- controlled study that enrolled,095 cases with mCRPC( with no systemic treatments initiated after attestation of mCRPC) at spots in theU.S., Canada, Europe, South America, and the Asia- Pacific region. The study included two patient cohorts each- moneybags( n = 750) and those with HRR mutations( HRRm; n = 380). Cases on androgen privation remedy( ADT) or who had bilateral orchiectomy in the trial were randomized to admit TALZENNA0.5 mg/ day plus XTANDI 160mg/ day, or placebo plus XTANDI 160 mg/ day.
The primary endpoint of the trial is radiographic progression-free survival( rPFS), defined as the time from the date of randomization to first objective substantiation of radiographic progression by dazed independent review, or death, whichever occurs first, in both cohort 1( each- moneybags) and cohort 2( those with HRRm). The trial is still ongoing for cohort 2. Secondary endpoints include overall survival, objective response rate, duration of response and PSA response.

For further information on the TALAPRO- 2 trial( NCT03395197) go towww.clinicaltrials.gov.
About TALZENNA ®( talazoparib)

TALZENNA( talazoparib) is an asset of PARP enzymes, which play a part in the DNA damage form response. Preclinical studies have demonstrated that TALZENNA blocks PARP enzyme exertion and traps PARP at the point of DNA damage, leading to dropped cancer cell growth and cancer cell death. TALZENNA is being estimated in several ongoing clinical trials in prostate cancer, as well as other new combinations with targeted curatives in colorful solid excrescences. TALZENNA was approved by theU.S. Food and Drug Administration in 2018 for the treatment of adult cases with injurious or suspected injurious germline bone cancer vulnerability gene( BRCA)- shifted( gBRCAm) mortal epidermal growth factor receptor 2( HER2)-negative locally advanced or metastatic bone cancer.
About Pfizer Oncology

At Pfizer Oncology, we’re committed to advancing drugs wherever we believe we can make a meaningful difference in the lives of people living with cancer. moment, we’ve an assiduity- leading portfolio of 24 approved innovative cancer drugs and biosimilars across further than 30 suggestions, including bone, genitourinary, colorectal, blood and lung cancers, as well as carcinoma.
About the Pfizer/ Astellas Collaboration

In October 2009, Medivation,Inc., which is now part of Pfizer( NYSE PFE), and Astellas( TSE 4503) entered into a global agreement to concertedly develop and manipulate enzalutamide. The companies concertedly manipulate XTANDI in the United States and Astellas has responsibility for manufacturing and all fresh nonsupervisory forms encyclopedically, as well as commercializing XTANDI outside the United States.

Source link:https://www.pfizer.com/