BRCA1/2 mutation platinum-sensitive relapsed ovarian cancer: Olapali is more effective at improving PFS than non-platinum chemotherapy

In patients with ovarian cancer with BRCA mutations, platinum-sensitive relapses, and at least second-line platinum-based chemotherapy, improvements in Orapali's objective remission rate (ORR) and non-progressive lifetime (PFS) were both statistically significant and clinically significant compared to non-platinum chemotherapy, according to a Phase III trial reported by Massachusetts General Hospital Penson. 2020 doi: 10.1200/JCO.19.02745) A Phase II study (registered at clinicaltrials.gov, No.NCT0) 0628251) showed that in patients with platinum-resistant or platinum-sensitive relapsed ovarian cancer with BRCA mutations in the embryo line, Olapali capsules showed activity relative to polyethyl glycol liposome polyflexosomes.
The Phase III. Phase III Trial (SOLO3) compared the efficacy of Olapali tablets with non-platinum chemotherapy in patients with ovarian cancer patients with BRCA mutations in the embryo line, platinum-sensitive recurrence, and who had received at least second-line platinum-based chemotherapy.
In this randomized, open-labeled trial, patients were randomly assigned to receive olapali (300 mg, bid) or non-platinum single-drug chemotherapy drugs (polyethyl glycol liposome polyjust, yew alcohol, gisitamine or topological tylenol) selected by the doctor on a scale of 2:1.
end point of the disease is the ORR of the Independent Evaluation Center (BICR) blind method assessment of measurable diseases.
secondary endpoint is PFS for intentional treatment populations assessed by BICR.
of the 266 patients randomly assigned, 178 received Olapali and 88 received chemotherapy.
In patients with measurable diseases (151 cases in the Olapali group and 72 in the chemotherapy group), the ORR in the Olapali group assessed by BICR was significantly higher than in the chemotherapy group (72.2% vs.51.4%;
in subgroups that had received second-line treatment, orR was 84.6% in the Olapali group and 61.5% in the chemotherapy group (OR=3.44, 95% CI1.42 to 8.54).
the chemotherapy group, biCR-assessed PFS was also significantly biased towards the Olapali group (OR=0.62,95%CI0.43 to 0.91, P=0.013; medium PFS:13.4 months vs. 9.2 months).
adverse events were consistent with the established safety data for Olapali and chemotherapy.
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