- Center on Health Equity and Access
- Clinical
- Health Care Cost
- Health Care Delivery
- Insurance
- Policy
- Technology
- Value-Based Care
OlympiAD Trial Reports Success With Olaparib and Predictive Diagnostic Test
The trial successfully improved progression-free survival and also tested a BRCA diagnostic test in patients with ovarian cancer.
A phase 3 trial evaluating olaparib (Lynparza) against standard of care chemotherapy in women with HER2-negative metastatic breast cancer has seen significant improvement in progression-free survival (PFS) with olaparib. Additionally, the trial has also reported that a BRCA diagnostic test could successfully identify positive responders to olaparib.
The trial, OlympiAD, is a randomized, multi-center study designed to study whether olaparib is safer and more effective than physicians’ choice of chemotherapy: capecitabine, vinorelbine, or eribulin. The trial, which has global sites, was conducted in 302 patients with HER2-negative metastatic breast cancer, with germline BRCA1/2 mutations. PFS was the primary trial end point; secondary endpoints included overall survival, time to second progression or death, objective response rate, and effect on health-related quality of life.
In a press release announcing the results, executive vice president of the Global Medicines Development at AstraZeneca, which is developing the drug, said “These results are positive news for patients with BRCA-mutated metastatic breast cancer, a disease with a high unmet need, and are the first positive phase 3 data for a PARP inhibitor beyond ovarian cancer.”
The OlympiAD study also successfully tested BRACAnalysis CDx, an FDA-approved genetic test that detects BRCA mutations in patients with HER2-negative breast cancer. In this trial, BRACAnalysis CDx identified patients who responded to olaparib. Of the 302 patients in the study, 297 (98%) tested positive for germline BRCA1/2 mutations.
Johnathan Lancaster, MD, PhD, chief medical officer of Myriad Genetic Laboratories, which has developed the diagnostic test, said that BRACAnalysis CDx can inform clinical treatment decisions in metastatic breast cancer and “expand the patient population who can benefit from BRCA testing.”
BRACAnalysis CDx is the first laboratory-developed companion diagnostic (CD) test to be FDA- approved. It was approved as a CD for olaparib to be used in the fourth-line setting for patients with ovarian cancer in 2014.
AstraZeneca is working toward submitting olaparib for an FDA review.
What We’re Reading: RSV Vaccine Demand; Permanent Contraception; Drug Negotiation Impact
December 8th 2023The Biden administration recently met with manufacturers of respiratory syncytial virus (RSV) immunizations to encourage them to increase access to the vaccine; since the Dobbs v Jackson decision, many patients have been seeking more permanent reproductive health care solutions; a Mathematica analysis showed that Medicare prescription drug price negotiations could have cut seniors’ out-of-pocket costs by nearly a quarter had the program been in effect in 2021.
Read More
Patients With HFrEF, HFpEF See Different Functional Capacity Benefits With Dapagliflozin
December 7th 2023The DETERMINE-Reduced and DETERMINE-Preserved trials demonstrated varying benefits of dapagliflozin on Kansas City Cardiomyopathy Questionnaire Total Symptom Score and Physical Limitation Scale as well as 6-minute walk distance.
Read More
Black Patients With Ulcerative Colitis Less Likely to Undergo IPAA Than White Patients
December 7th 2023Overall, the number of patients discharged from hospitals with an ulcerative colitis diagnosis increased between 2009 and 2018, but the number of patients opting for ileal pouch–anal anastomosis (IPAA) decreased.
Read More
Prediction Model Identified Risk Factors for ED Visits in Patients With Lung Cancer
December 7th 2023A risk prediction model that was based on machine learning could help to make resource utilization more efficient by correctly predicting emergency department (ED) visits in patients with lung cancer.
Read More
