#ESMO22: At five-year mark, Lynparza kept more patients alive than Avastin but missed overall OS significance
09 Sep 2022
PARIS — AstraZeneca and Merck arrived at ESMO with long-term data on their blockbuster cancer drug and European confab staple Lynparza, which ushered in the PARP inhibitorPARP inhibitor market in December 2014.
The datasets this time around were a mixed bag — the Big Pharma partners detailed five-year follow-up results to the PAOLA-1 Phase III and seven-year analysis of the SOLO-1 Phase III, two trials that have drummed up plenty of interest at the annual oncology meetup across the pond.
Looking at the first-line advanced ovarian cancer setting, the trials showed a higher percentage of patients on Lynparza were still alive versus the comparators, but did not clock in with statistical significance among all patients. On the flip side, researchers had yet to reach median overall survival in the SOLO-1 study, despite it being seven years.
When taking a bird’s-eye view of the two trials combined, which equates to almost 1,200 patients, the results look pretty good — two out of three patients were still alive, according to AstraZeneca’s oncology leader Susan Galbraith. Historically, only 30-50% of newly diagnosed patients with advanced forms of ovarian cancer will live for five years, she said.
Merck CMO Eliav Barr was clinical and concise in his statement, noting Lynparza, as a maintenance therapy, “may provide” very specific patients — HRD-positive and/or BRCA-mutated — “the opportunity to live longer.”
Preview
Source: Endpts
Eliav Barr
On median OS in the PAOLA-1 study, Lynparza plus cancer drug Avastin was not statistically significant at five years; the combo increased the mark by 56.5 months versus 51.6 months in the Avastin alone arm. When looking specifically at HRD-positive patients, Lynparza plus Avastin showed a “clinically meaningful improvement” on the OS mark with risk of death 38% lower versus Avastin alone, based on a hazard ratio of 0.62, the companies reported Friday.
A survival snapshot showed the combo arm had 65.5% of patients still alive at the five-year threshold, versus 48.4% in the comparator group.
PFS numbers in the PAOLA-1 study were vastly different. The combo group had an improved median PFS of 46.8 months versus 17.6 months, and the percentage of patients remaining progression-free at half a decade was 46.1% versus 19.2%.
The SOLO-1 trial showed that Lynparza was not statistically significant on the OS mark versus placebo in patients harboring BRCA mutation. The risk of death was reduced by 45%, based on a hazard ratio of 0.55, which came in below significance but what the companies touted as “clinically meaningful improvement.”
At seven years, 67% of patients on the Big Pharma’s drug were alive, well above the 47% of placebo patients. Of the patients on placebo, 44% wound up receiving a PARP inhibitorPARP inhibitor later on. Almost half of the Lynparza patients had not received a subsequent treatment for their cancer. That 45% figure was more than double the placebo group, which came in at 21%.
For Lynparza patients who did go on another therapy, it was a median time of 64 months before they did so, versus 15.1 months for the placebo group.
The companies reported no new safety signals in the long-term follow-ups.
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