AZ, MSD’s Lynparza/Abiraterone Combo Hits Prostate Cancer Goals

Excerpt:

“AstraZeneca and MSD have presented data at ASCO showing improvement in radiologic progression-free survival (rPFS) in prostate cancer patients taking a combination of Lynparza and abiraterone.

“Study 08 – a randomised, double-blinded, multi-centre Phase II trial – compared Lynparza (olaparib) in combination with abiraterone to abiraterone alone in patients with previously-treated metastatic castration-resistant prostate cancer, (mCRPC), regardless of homologous recombination repair (HRR) mutation status.”

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Olaparib in Breast Cancer: PFS Is Significant but OS Is Not

Excerpt:

“A few months ago, olaparib (Lynparza, AstraZeneca) was the first drug approved to treat women with advanced breast cancer with germline mutations in BRCA.

“That approval was based on a significant improvement in progression-free survival (PFS) compared with standard chemotherapy shown in the OlympiAD trial. The results led to quite some excitement among breast cancer researchers, as for example in the Medscape Oncology commentary ‘OlympiAD: Olaparib Captures Gold for BRCA-Mutated Breast Cancer Patients.’

“Now, however, a final analysis of OlympiAD results shows that overall survival (OS) did not significantly improve.”

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Olaparib Breast Cancer Efficacy Highlighted in Added Analyses

Excerpt:

“Improvements in progression-free survival (PFS) with olaparib (Lynparza) over treatment of physician’s choice (TPC) remained consistent regardless of baseline tumor burden for patients with HER2-negative breast cancer with a germline BRCA1/2 mutation (gBRCA1/2m), according to an exploratory analysis from the phase III OlympiAD trial presented at the 2018 Miami Breast Cancer Conference (MBCC).

“Although not powered to show statistical significance between the groups, in those with one metastatic site (n = 71) the median PFS with olaparib was 8.4 months compared with 4.2 months with TPC (HR, 0.62; 95% CI, 0.35-1.13). In patients with ≥2 metastatic sites (n = 231), the median PFS was 6.5 months with olaparib compared with 3.0 months for TPC, which crossed the barrier for statistical significance (HR, 0.59; 95% CI, 0.43-0.82).”

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FDA Approves First Treatment for Breast Cancer with a Certain Inherited Genetic Mutation

Excerpt:

“The U.S. Food and Drug Administration today expanded the approved use of Lynparza (olaparib tablets) to include the treatment of patients with certain types of breast cancer that have spread (metastasized) and whose tumors have a specific inherited (germline) genetic mutation, making it the first drug in its class (PARP inhibitor) approved to treat breast cancer, and it is the first time any drug has been approved to treat certain patients with metastatic breast cancer who have a “BRCA” gene mutation. Patients are selected for treatment with Lynparza based on an FDA-approved genetic test, called the BRACAnalysis CDx.”

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Immunotherapy Continues Growth With Trials in mCRPC

Excerpt:

“Although modern immunotherapy has yet to have a breakthrough in prostate cancer to the degree it has had in lung cancer or urothelial carcinoma, combinations with anti–PD-1/PD-L1 agents are beginning to show promise for these patients in clinical trials.

“Currently ongoing is a phase II trial of durvalumab (Imfinzi) in combination with the PARP inhibitor olaparib (Lynparza) in patients with metastatic castration-resistant prostate cancer (mCRPC; NCT02484404). Investigators note that previous data have suggested that 25% to 30% of sporadic mCRPC has DNA-repair pathway defects. Results thus far have demonstrated that the synergy of durvalumab and olaparib proves that the combination may be a viable option for patients with mCRPC who are heavily pretreated. The trial is still accruing.”

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Astra and Merck Win Speedy Review for Lynparza in Breast Cancer

Excerpt:

“U.S. regulators have granted a priority review to AstraZeneca’s ovarian cancer drug Lynparza as a treatment for breast cancer, putting it on track for potential approval in the new disease area during the first quarter of 2018.

“The medicine, which is being jointly developed and marketed with Merck under a deal struck in July, is the first poly ADP-ribose polymerase (PARP) drug to be considered for use outside ovarian cancer.”

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AstraZeneca’s Lynparza Slows Spread of Inherited Breast Cancer

Excerpt:

AstraZeneca Plc showed that its drug Lynparza slowed progression of a devastating, inherited form of breast cancer that typically strikes younger women, potentially opening up a new market for a pill originally approved to treat ovarian tumors.

“A study of 302 women, dubbed OlympiAD, found that those getting the drug were 42 percent less likely to see their cancer spread than those given conventional chemotherapy, according to results presented at the American Society of Clinical Oncology meeting in Chicago. Women taking Lynparza had their disease progress after about seven months, compared with 4.2 months of median progression-free survival for those on chemotherapy.”

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Lynparza Meets Primary Endpoint in Phase III Trial in BRCA-Mutated Metastatic Breast Cancer

Excerpt:

“AstraZeneca today announced positive results from its Phase III OLYMPIAD trial comparing Lynparza (olaparib) tablets (300mg twice daily) to physician’s choice of a standard of care chemotherapy in the treatment of patients with HER2-negative metastatic breast cancer harbouring germline BRCA1 or BRCA2 mutations. Patients treated with Lynparza showed a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) compared with those who received chemotherapy (capecitabine, vinorelbine or eribulin).”

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FDA Grants Olaparib Breakthrough Designation in mCRPC

“Olaparib (Lynparza) has received an FDA breakthrough therapy designation as a treatment for patients with BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer (mCRPC) in those who have received a prior taxane-based chemotherapy and at least either hormonal agent enzalutamide (Xtandi) or abiraterone acetate (Zytiga).

“The designation, which will accelerate the development and review of the first-in-class oral PARP inhibitor, is based on data from the phase II TOPARP-A trial that demonstrated that olaparib monotherapy had an overall response rate (ORR) of nearly 90% in a biomarker-defined subgroup of patients who had DNA-repair defects.