Lynparza Better Than Chemo for BRCA-mutated Advanced Ovarian Cancer, Phase 3 Trial Shows

Lynparza (olaparib), given to advanced ovarian cancer patients with BRCA mutations who were previously treated with at least two lines of platinum chemotherapy, had significantly better response rates and progression-free survival times than those given chemotherapy, full results from the SOLO-3 Phase 3 trial show.

These findings make Lynparza the first and only PARP inhibitor to outperform standard chemotherapy in this patient group, AstraZeneca and Merck (known as MSD outside North America), which jointly develop Lynparza, announced in a press release.

An oral presentation at the 2019 American Society of Clinical Oncology (ASCO) annual meeting in Chicago, titled “Olaparib monotherapy versus (vs) chemotherapy for germline BRCA-mutated (gBRCAm) platinum-sensitive relapsed ovarian cancer (PSR OC) patients (pts): Phase III SOLO3 trial,” detailed the results.

SOLO-3 (NCT02282020) was a randomized, open-label and placebo-controlled study evaluating if Lynparza is better than chemotherapy at treating germline (inherited) BRCA-mutated advanced ovarian cancer.

It enrolled 266 women who had already undergone two prior treatment regimens and had responded to their last platinum-based chemotherapy regimen. Participants were randomly assigned 300 mg Lynparza tablets twice daily or a non-platinum chemotherapy of their physician’s choice — paclitaxel, Hycamtin (topotecan), gemcitabine, or liposomal doxorubicin.

Overall, 72% of patients given Lynparza responded to treatment, compared to 51% of those on chemotherapy. Lynparza also reduced the risk of disease progression by 38%, with patients on that treatment living a median of 13.4 months without disease worsening compared to 9.2 months in the chemotherapy group.

“Lynparza provides a much-needed alternative and improvement over standard-of-care chemotherapy for patients with BRCA-mutated, advanced ovarian cancer,” José Baselga, executive vice president of oncology R&D, said in the release.

“This is the fourth positive Phase 2/3 trial in advanced ovarian cancer for Lynparza, across multiple lines of therapy,” he added.

Lynparza’s safety and tolerability in SOLO-3 patients was consistent with those in previous trials. The most common side effects were nausea, fatigue, anemia, vomiting, diarrhea, and abdominal pain. Adverse events led to treatment discontinuation in 7% of patients using Lynparza and 20% of those on chemotherapy.

“We look forward to working closely with regulatory authorities to include findings from this trial in the prescribing information for Lynparza,” Baselga said.

Lynparza is currently available in more than 60 countries to treat platinum-sensitive relapsed ovarian cancer, regardless of BRCA mutation status.

It is also used for women with BRCA-mutated advanced ovarian cancer who have been treated with at least three chemotherapy treatments, and as maintenance therapy for women with BRCA-mutated relapsed ovarian cancer whose tumors responded to platinum-based chemotherapy.