AstraZeneca ( NASDAQ: AZN ) and Merck's ( NYSE: MRK ) Lynparza showed clinically meaningful survival benefit as first line therapy in certain patients with ovarian cancer as per long-term data from two phase 3 trials.
AstraZeneca presented 5-year follow-up data from a phase 3 study, called PAOLA-1, of Lynparza (olaparib) as a combination therapy; and long-term data from a phase 3 study, dubbed SOLO-1, of Lynparza monotherapy at the 2022 European Society of Medical Oncology (ESMO).
PAOLA-1 :
Updated data from PAOLA-1 showed that Lynparza plus Roche's ( OTCQX:RHHBY ) ( OTCQX:RHHBF ) Avastin (bevacizumab) increased median Overall Survival (OS) to 56.5 months, compared to 51.6 months with bevacizumab alone, in patients with newly diagnosed advanced ovarian cancer irrespective of HRD status but this increase was not statistically significant, AstraZeneca said in a Sept. 9 press release.
However, in HRD-positive patients, Lynparza plus Avastin provided a clinically meaningful improvement in overall survival, reducing the risk of death by 38%, compared to Avastin, the company added.
AstraZeneca noted that 65.5% of patients treated with Lynparza plus Avastin were still alive at five years versus 48.4% of those treated with Avastin alone.
The Lynparza/Avastin combo also improved median Progression-free survival (PFS - length of time during/after therapy a patient lives with the disease without it getting worse) to almost four years (46.8 months) versus 17.6 months with Avastin plus placebo.
In addition, 46.1% of patients on Lynparza/Avastin remain progression free at five years, compared to 19.2% of patients on Avastin alone.
SOLO-1 :
Updated results from the SOLO-1 showed that Lynparza provided a clinically meaningful improvement in OS versus placebo in patients with BRCA-mutated (BRCAm) newly diagnosed advanced ovarian cancer, reducing the risk of death by 45%, the British pharma giant said.
AstraZeneca noted that median OS was still not reached with Lynparza, compared to 75.2 months for placebo.
At the seven-year OS analysis, 67% of Lynparza patients were alive versus 47% of placebo patients.
In addition, median time to first subsequent therapy was 64 months with Lynparza versus 15.1 months with placebo, according to the company.
AstraZeneca said that the safety profile of Lynparza in both trials was in line with what has been seen in prior studies.
AZN +1.82% to $61.42 premarket Sept. 9
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AstraZeneca/Merck's Lynparza shows survival benefit in ovarian cancer patients in long-term data