NATIONAL HARBOR, MD. – Maintenance therapy with the first-in-class PARP inhibitor olaparib was associated with a striking improvement in progression-free survival in patients with platinum-sensitive relapsed ovarian cancer and BRCA 1/2 mutation in the randomized, placebo-controlled phase III SOLO2 trial.
Compared with placebo, the tablet formulation of olaparib was associated with investigator-assessed PFS of 19.1 months in 196 patients, compared with 5.5 months in 99 patients who received placebo (hazard ratio, 0.30), Dr. Eric Pujade-Lauraine reported at the annual meeting of the Society of Gynecologic Oncology.
The SOLO2 results were both clinically meaningful and highly statistically significant, said Dr. Pujade-Lauraine of Hopital Hotel-Dieu, Paris.
Active treatment, which involved a twice-daily 300-mg oral dose of olaparib, was well tolerated; 75% of patients completed the study without dose reduction, he noted.
In this video interview, Dr. Pujade-Lauraine discussed the SOLO2 study and findings, which confirmed those of the phase II Study 19. Study 19 looked at olaparib in all-comers with platinum-sensitive relapsed ovarian cancer and involved a different formulation of the drug, which required that patients take 16 capsules each day to achieve a twice-daily dose of 400 mg. Patients with BRCA mutations were found in that study to derive the most benefit from olaparib.
The current findings are practice changing, Dr. Pujade-Lauraine said, concluding that “it is important to test BRCA, and if this test is positive, to offer olaparib in patients who are platinum sensitive.”