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Therapeutic efficacy of Olaparib

The efficacy of Lynparza was investigated in two randomized, placebo-controlled, double-blind, multicenter studies in patients with recurrent ovarian cancers who were in response to platinum-based therapy

SOLO-2  

SOLO-2 (NCT01874353) was a double-blind, placebo-controlled trial in which patients (N=295) with  germline BRCA-mutated (gBRCAm) ovarian, fallopian tube, or primary peritoneal cancer were  randomized (2:1) to receive Lynparza tablets 300 mg orally twice daily or placebo until unacceptable  toxicity or progressive disease. Randomization was stratified by response to last platinum chemotherapy  (complete versus partial) and time to disease progression in the penultimate platinum-based chemotherapy prior to enrollment (6-12 months versus > 12 months). All patients had received at least two prior  platinum-containing regimens and were in response (complete or partial) to their most recent platinumbased regimen. All patients had a deleterious or suspected deleterious germline BRCA-mutation as  detected either by a local test (n= 236) or central Myriad CLIA test (n=59), subsequently confirmed by  BRAC Analysis CDx (n= 286).

The major efficacy outcome was investigator-assessed progression-free survival (PFS) evaluated  according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. Additional endpoints  included overall survival (OS).

The median age of patients treated with Lynparza was 56 years (range: 28 to 83) and 56 years (range: 39  to 78) among patients treated with placebo. ECOG performance score was 0 in 83% of patients receiving  Lynparza and 78% of patients receiving placebo. Of all patients, 89% were White, 17% were enrolled in  the U.S. or Canada, 47% were in complete response to their most recent platinum-based regimen, and  40% had a progression-free interval of 6-12 months since their penultimate platinum regimen. Prior  bevacizumab therapy was reported for 17% of those treated with Lynparza and 20% of those receiving  placebo. Approximately 44% of patients on the Lynparza arm and 37% on placebo had received three or  more lines of platinum-based treatment.

SOLO-2 demonstrated a statistically significant improvement in investigator-assessed PFS in patients  randomized to Lynparza as compared with placebo (Table 7 and Figure 1). Results from a blinded  independent review were consistent. At the time of the analysis of PFS, overall survival (OS) data were  not mature with 24% of events.  

FDA,2021.08