PARP inhibitors

First Participant Dosed in Pfizer’s Pivotal Phase 3 TALAPRO-3 Combination Study of Talazoparib and Enzalutamide in Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

Retrieved on: 
Wednesday, June 23, 2021

The study will evaluate the efficacy and safety of talazoparib, an oral poly (ADP-ribose) polymerase (PARP) inhibitor, in combination with enzalutamide, an androgen receptor inhibitor, compared with placebo plus enzalutamide in men with DNA damage response (DDR)-deficient metastatic castration-sensitive prostate cancer (mCSPC).

Key Points: 
  • The study will evaluate the efficacy and safety of talazoparib, an oral poly (ADP-ribose) polymerase (PARP) inhibitor, in combination with enzalutamide, an androgen receptor inhibitor, compared with placebo plus enzalutamide in men with DNA damage response (DDR)-deficient metastatic castration-sensitive prostate cancer (mCSPC).
  • The primary endpoint of the study is radiographic progression-free survival (rPFS), and overall survival (OS) is a secondary endpoint.
  • Talazoparib is currently approved under the brand name TALZENNA for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer.
  • Talazoparib is being evaluated in several ongoing clinical trials in prostate cancer, as well as other novel combinations with targeted therapies in various solid tumors.

LYNPARZA® (olaparib) reduced the risk of cancer recurrence by 42% in the adjuvant treatment of patients with germline BRCA-mutated high-risk early breast cancer in OlympiA Phase III trial

Retrieved on: 
Thursday, June 3, 2021

The safety and tolerability profile of LYNPARZA in this trial was in line with that observed in prior clinical trials.

Key Points: 
  • The safety and tolerability profile of LYNPARZA in this trial was in line with that observed in prior clinical trials.
  • LYNPARZA is not currently approved for the adjuvant treatment of gBRCAm high-risk HER2-negative early breast cancer.
  • PARP inhibitor, LYNPARZA (olaparib) is a targeted treatment option for patients with germline BRCA-mutated HER2-negative metastatic breast cancer.
  • Olaparib as Adjuvant Treatment in Patients with Germline BRCA-mutated High Risk HER2 Negative Primary Breast Cancer (OlympiA).

Clovis Oncology’s Rubraca® (rucaparib) Significantly Improves Progression-Free Survival versus Chemotherapy in Patients with Later-line Ovarian Cancer Associated with a BRCA Mutation

Retrieved on: 
Friday, March 19, 2021

The data demonstrate that Rubraca significantly improves PFS compared to standard-of-care chemotherapy, including platinum-based chemotherapy, among patients with advanced, relapsed ovarian cancer and a deleterious BRCA mutation who have received two or more prior lines of chemotherapy.

Key Points: 
  • The data demonstrate that Rubraca significantly improves PFS compared to standard-of-care chemotherapy, including platinum-based chemotherapy, among patients with advanced, relapsed ovarian cancer and a deleterious BRCA mutation who have received two or more prior lines of chemotherapy.
  • The primary efficacy population (n=325) comprised the group of patients with a deleterious tumor BRCA mutation and excluded those with a BRCA reversion mutation as determined by a blood test.
  • The median PFS for the patients in the efficacy population treated with rucaparib was 7.4 months versus 5.7 months among those who received chemotherapy.
  • The median PFS for the patients in the ITT population treated with rucaparib was 7.4 months versus 5.7 months among those who received chemotherapy.

Recent Developments in the Ovarian Cancer Market - Key Opinion Leader Views - ResearchAndMarkets.com

Retrieved on: 
Monday, March 15, 2021

This report presents key opinion leader (KOL) views on recent developments in the ovarian cancer market.

Key Points: 
  • This report presents key opinion leader (KOL) views on recent developments in the ovarian cancer market.
  • Is Zejula likely to displace other PARP inhibitors already available on the market for the treatment of ovarian cancer?
  • Should Rubraca's sNDA receive FDA approval, how likely is the drug to gain extensive market share ahead of its competitors?
  • What is the view of the experts on having three PARP inhibitors for the treatment of ovarian cancer?

AstraZeneca Demonstrates Growing Leadership in Breast Cancer at SABCS with Data From Its Innovative Medicines and Robust Pipeline

Retrieved on: 
Thursday, December 3, 2020

In clinical studies, of the 234 patients with unresectable or metastatic HER2-positive breast cancer treated with ENHERTU, ILD occurred in 9% of patients.

Key Points: 
  • In clinical studies, of the 234 patients with unresectable or metastatic HER2-positive breast cancer treated with ENHERTU, ILD occurred in 9% of patients.
  • AstraZeneca aims to continue to transform outcomes for HR-positive breast cancer with foundational medicines fulvestrant and goserelin and the next-generation SERD and potential new medicine AZD9833.
  • PARP inhibitor, LYNPARZA (olaparib), was the first targeted treatment option for metastatic breast cancer patients with an inherited BRCA mutation.
  • AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

Lynparza® (olaparib) Receives Health Canada Approval for the Treatment of BRCA or ATM Gene-Mutated Metastatic Castration-Resistant Prostate Cancer

Retrieved on: 
Wednesday, November 25, 2020

The Notice of Compliance was granted under priority review and marks the first Health Canada approval of a PARP inhibitor in prostate cancer.

Key Points: 
  • The Notice of Compliance was granted under priority review and marks the first Health Canada approval of a PARP inhibitor in prostate cancer.
  • "This new approval offers patients a much-needed new treatment option, and also reinforces the importance of BRCA and ATM testing."
  • The Health Canada approval of Lynparza for BRCA or ATM gene-mutated mCRPC was based on data from Cohort A of the global Phase III PROfound trial.
  • Based on the available clinical trial data, a causal association between Lynparza treatment and VTE including pulmonary embolism has not been established.

New Research in JNCCN Evaluates Cost-Effectiveness of Olaparib, a PARP Inhibitor, for Metastatic Pancreatic Cancer

Retrieved on: 
Thursday, November 12, 2020

Thus, either improved patient selection for maintenance olaparib or reduced drug costs are likely necessary to establish olaparib as a cost-effective therapy in metastatic pancreatic cancer."

Key Points: 
  • Thus, either improved patient selection for maintenance olaparib or reduced drug costs are likely necessary to establish olaparib as a cost-effective therapy in metastatic pancreatic cancer."
  • Complimentary access to " Cost-Effectiveness of Maintenance Olaparib for Germline BRCA-Mutated Metastatic Pancreatic Cancer " is available until February 10, 2021.
  • More than 25,000 oncologists and other cancer care professionals across the United States readJNCCNJournal of the National Comprehensive Cancer Network.
  • The National Comprehensive Cancer Network ( NCCN ) is a not-for-profit alliance of leading cancer centers devoted to patient care, research, and education.

FDA Approves New FoundationOne®Liquid CDx Companion Diagnostic Indications for Three Targeted Therapies That Treat Advanced Ovarian, Breast and Non-Small Cell Lung Cancer

Retrieved on: 
Tuesday, October 27, 2020

Foundation Medicine, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved FoundationOneLiquid CDx for three new companion diagnostic indications to help match patients who may benefit from treatment with specific FDA-approved targeted therapies.

Key Points: 
  • Foundation Medicine, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved FoundationOneLiquid CDx for three new companion diagnostic indications to help match patients who may benefit from treatment with specific FDA-approved targeted therapies.
  • The new indications are for Piqray (alpelisib) in advanced or metastatic breast cancer; Rubraca (rucaparib) in advanced ovarian cancer; and Alecensa (alectinib) in a certain type of metastatic non-small cell lung cancer (mNSCLC).
  • The FDA also approved a label expansion for FoundationOne Liquid CDx to report additional select copy number alterations and genomic rearrangements.
  • For the complete label, including companion diagnostic indications and complete risk information, please visit www.F1LCDxLabel.com .

SEngine Precision Medicine’s PARIS® Test Identifies Novel Drug Combinations for PARP Inhibitor Resistant Ovarian Cancer in Study Published in EBioMedicine

Retrieved on: 
Tuesday, October 20, 2020

SEATTLE, Oct. 20, 2020 (GLOBE NEWSWIRE) -- SEngine Precision Medicine ,a precision oncology company revolutionizing cancer diagnostics anddrug discoveryby pre-testing drugs on patient-derivedtumor organoids, announced today that the PARIS Test was utilized in a study to identify novel drug combinations to overcome resistance to PARP inhibitors in ovarian cancer.

Key Points: 
  • SEATTLE, Oct. 20, 2020 (GLOBE NEWSWIRE) -- SEngine Precision Medicine ,a precision oncology company revolutionizing cancer diagnostics anddrug discoveryby pre-testing drugs on patient-derivedtumor organoids, announced today that the PARIS Test was utilized in a study to identify novel drug combinations to overcome resistance to PARP inhibitors in ovarian cancer.
  • PARP inhibitors are targeted drugs that have become the standard of care in the treatment of nearly half of ovarian cancers.
  • In this study, researchers used a combination of high throughput siRNA screening and drug testing assays using patient derived tumor cells to identify clinically relevant drug combinations for patients whose tumors were resistant to PARP inhibitors.
  • While we could not help this first patient, this study nominates a novel drug combination for PARP inhibitor resistant ovarian cancer, which could be tested in clinical trials.

LYNPARZA® (olaparib) Recommended for Approval in EU by CHMP as First-Line Maintenance Treatment with Bevacizumab for HRD-Positive Advanced Ovarian Cancer

Retrieved on: 
Monday, September 21, 2020

The addition of LYNPARZA to bevacizumab improved progression-free survival (PFS) to a median of 37.2 months vs. 17.7 months with bevacizumab alone in patients with HRD-positive advanced ovarian cancer.

Key Points: 
  • The addition of LYNPARZA to bevacizumab improved progression-free survival (PFS) to a median of 37.2 months vs. 17.7 months with bevacizumab alone in patients with HRD-positive advanced ovarian cancer.
  • Discontinuation of treatment due to ARs occurred in 20% of patients on LYNPARZA in combination with bevacizumab.
  • For patients with advanced ovarian cancer, the primary aim of first-line maintenance treatment is to delay disease progression for as long as possible.
  • Dr. Jos Baselga, executive vice president, oncology R&D, AstraZeneca, said, Half of all patients with advanced ovarian cancer have HRD-positive tumors.