AstraZeneca Announce Lynparza achieved a 72% objective response rate in patients with relapsed, germline BRCA-mutated advanced ovarian cancer

AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) today presented full results from the Phase III SOLO3 trial which compared Lynparza (olaparib) with physician’s choice of chemotherapy in the treatment of patients with germline BRCA1/2-mutated (gBRCAm) advanced ovarian cancer who had received two or more prior lines of chemotherapy.

The results from the trial, presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, US, showed a statistically-significant and clinically-meaningful improvement in objective response rate (ORR) for Lynparza vs. chemotherapy (72.2% vs. 51.4% [95% CI, 1.40-4.58], p=0.002). ORR measures the proportion of patients with reduction in tumour burden of a predefined percentage.

The trial also met the key secondary endpoint of progression-free survival (PFS), demonstrating a statistically-significant and clinically-meaningful improvement in the time patients lived without disease progression for Lynparza (13.4 months) vs. chemotherapy (9.2 months [HR 0.62] p=0.013]).

José Baselga, Executive Vice President, Oncology R&D, said: “Lynparza provides a much-needed alternative and improvement over standard-of-care chemotherapy for patients with BRCA-mutated, advanced ovarian cancer. This is the fourth positive Phase II/III trial in advanced ovarian cancer for Lynparza, across multiple lines of therapy. We look forward to working closely with regulatory authorities to include findings from this trial in the prescribing information for Lynparza.”

Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: “Lynparza is the first and only PARP inhibitor to demonstrate efficacy versus chemotherapy in relapsed BRCA-mutated advanced ovarian cancer following response to platinum-based chemotherapy. The positive SOLO3 results reaffirm AstraZeneca and MSD’s ongoing commitment to explore potential treatment options beyond standard of care for BRCA-mutated with advanced stage disease.”

Summary of resultsi

  Lynparza
(300 mg bd)
Chemotherapy
ORR (primary endpoint)  
Number of patients 151 72
Number of patients with response (%) 109 (72.2%) 37 (51.4%)
Odds ratio (95% CI) 2.53 (1.40, 4.58)
p-value 0.002
PFS (key secondary endpoint)i,ii  
Number of patients 178 88
Number of patients with event (%) 110 (61.8%) 49 (55.7%)
Hazard ratio (95% CI) 0.62 (0.43, 0.91)
Median in months 13.4 9.2
p-value 0.013

iAssessed by blinded independent central review.

iiAnalysis was done at 59.8% maturity.

The safety and tolerability profile of Lynparza in the SOLO3 trial was consistent with previous trials. The most common adverse events (AEs) ≥ 20% were nausea (65%), fatigue/asthenia (52%), anaemia (51%), vomiting (38%), diarrhoea (28%), neutropenia (23%) and abdominal pain (21%). The most common ≥ Grade 3 AEs were anaemia (21%), neutropenia (10%), fatigue/asthenia (5%) and thrombocytopenia (4%). AEs led to dose interruption in 48% of patients on Lynparza while 7% of patients discontinued treatment.

Lynparza, which is being jointly developed and commercialised by AstraZeneca and MSD, is approved for multiple indications in advanced ovarian cancer and metastatic breast cancer and has been used in over 20,000 patients worldwide.

 



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