Overall Survival With Maintenance Olaparib at a 7-Year Follow-Up in Patients With Newly Diagnosed Advanced Ovarian Cancer and a BRCA Mutation: The SOLO1/GOG 3004 Trial

In SOLO1/GOG 3004 (ClinicalTrials.gov identifier: NCT01844986), maintenance therapy with the poly(ADP-ribose) polymerase inhibitor olaparib provided a sustained progression-free survival benefit in patients with newly diagnosed advanced ovarian cancer and a BRCA1 and/or BRCA2 (BRCA) mutation. We report overall survival (OS) after a 7-year follow-up, a clinically relevant time point and the longest follow-up for any poly(ADP-ribose) polymerase inhibitor in the first-line setting. METHODS: This double-blind phase III trial randomly assigned patients with newly diagnosed advanced ovarian cancer and a BRCA mutation in clinical response to platinum-based chemotherapy to maintenance olaparib (n = 260) or placebo (n = 131) for up to 2 years. A prespecified descriptive analysis of OS, a secondary end point, was conducted after a 7-year follow-up. RESULTS: The median duration of treatment was 24.6 months with olaparib and 13.9 months with placebo, and the median follow-up was 88.9 and 87.4 months, respectively. The hazard ratio for OS was 0.55 (95% CI, 0.40 to 0.76; P = .0004 [P < .0001 required to declare statistical significance]). At 7 years, 67.0% of olaparib patients versus 46.5% of placebo patients were alive, and 45.3% versus 20.6%, respectively, were alive and had not received a first subsequent treatment (Kaplan-Meier estimates). The incidence of myelodysplastic syndrome and acute myeloid leukemia remained low, and new primary malignancies remained balanced between treatment groups. CONCLUSION: Results indicate a clinically meaningful, albeit not statistically significant according to prespecified criteria, improvement in OS with maintenance olaparib in patients with newly diagnosed advanced ovarian cancer and a BRCA mutation and support the use of maintenance olaparib to achieve long-term remission in this setting; the potential for cure may also be enhanced. No new safety signals were observed during long-term follow-up

From Horizontal to Vertical: An Intermediary Liability Earthquake in Europe

As part of its Digital Single Market Strategy, the European Commission would like to introduce vertical regulations, replacing—or better conflicting with—the well-established eCommerce Directive horizontal intermediary liability regime.An upcoming revision of the Audio-visual Media Services Directive would ask platforms to put in place measures to protect minors from harmful content and to protect everyone from incitement to hatred. Meanwhile—under the assumption of closing a ‘value gap’ between rightholders and online platforms allegedly exploiting protected content—the Draft Directive on Copyright in the Digital Single Market would implement filtering obligations for intermediaries. Finally, the EU Digital Single Market Strategy has also endorsed voluntary measures as a privileged tool to curb illicit and infringing activities online.Each of these actions will erode the eCommerce intermediary liability arrangement by bringing in—in a way or another—proactive monitoring obligations and causing a systemic shift from a negligence-based to a strict liability regime for hosting providers. This systemic shift would apparently occur against public consensus and absent any justification based on empirical evidence. Nonetheless, it will bring about dire consequences by pushing privatization of enforcement online through algorithmic intelligence, based on murky, privately-enforced standards, rather than transparent legal obligations. This reform might cause a policy earthquake that will shake and crack EU law’s systemic consistency, due process and fundamental rights online