FDA Approval in Ovarian Cancer, Priority Reviews in NSCLC, CLL, and Follicular Lymphoma, and More

Today- An FDA approval in ovarian cancer, priority review designations in non—small cell lung cancer and chronic lymphocytic leukemia and follicular lymphoma, and encouraging phase III findings in hepatocellular carcinoma.

Welcome to OncLive News Network! I’m Gina Columbus.

The FDA has approved rucaparib tablets for use as a maintenance treatment for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

The approval is based on findings from the phase III ARIEL3 trial, in which the median progression-free survival in the overall study population was 10.8 month with the PARP inhibitor versus 5.4 months with placebo. The overall response rate with rucaparib was 18% versus 8% with placebo.

Additionally, for patients with germline or somatic BRCA mutations, there was a 77% reduction in the risk of progression or death with rucaparib versus placebo. The median PFS with rucaparib was 16.6 months compared with 5.4 months for placebo. Similar PFS benefits were observed in patients with BRCA wild-type tumors and those with homologous recombination deficiency or low to high loss of heterozygosity.

In addition to the maintenance approval, the FDA has also converted rucaparib's previous accelerated approval into a full approval for use as a monotherapy for the treatment of patients with ovarian cancer with a deleterious BRCA mutation following prior treatment with 2 or more chemotherapies.

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In non—small cell lung cancer, the FDA granted a priority review designation to dacomitinib for the frontline treatment of patients with EGFR-positive locally advanced or metastatic disease.

The designation is based on data from the phase III ARCHER 1050 trial, in which first-line dacomitinib reduced the risk of disease progression or death by more than 40% and resulted in an average 6.5-month improvement in response duration versus gefitinib in patients with advanced, EGFR-positive NSCLC.

Under the Prescription Drug User Fee Act, the FDA is scheduled to make its decision by September 2018. Pfizer, the developer of dacomitinib, also reported that the European Medicines Agency has accepted a marketing authorization application for dacomitinib for the same indication.

Results showed that the median progression-free survival for patients who received dacomitinib was 14.7 months compared with 9.2 months for participants who received gefitinib. The median duration of response was 14.8 months with dacomitinib versus 8.3 months with gefitinib.

Although PFS was similar in both arms at the 6-month mark, the difference in PFS was clear by 24 months, at which 30.6% of patients in the dacomitinib arm were progression free, compared with 9.6% in the gefitinib group. However, there was not a statistically significant difference in ORR, with 74.9% of patients in the dacomitinib arm achieving a response versus 71.6% of patients in the gefitinib arm. Overall survival data were not yet mature at the time of the analysis.

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The FDA has granted a priority review to a new drug application for the PI3K-delta and -gamma inhibitor duvelisib for a full approval for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma, and an accelerated approval for the treatment of patients with relapsed/refractory follicular lymphoma.

The application includes supporting findings from the phase III DUO trial and the phase II DYNAMO study. In DUO, duvelisib reduced the risk of disease progression or death by 48% versus ofatumumab in patients with relapsed/refractory CLL/SLL. In the overall population, the median progression-free survival with duvelisib was 3.4 months longer versus ofatumumab. In those with a 17p deletion, the median PFS benefit was 3.7 months.

In DYNAMO, duvelisib demonstrated an overall response rate of 46% for patients with indolent non-Hodgkin lymphoma, including 41% in patients with follicular lymphoma.

The ORRs in the SLL and marginal zone lymphoma groups were 68% and 33%, respectively. The median duration of response was 9.9 months. At a median follow-up of 11.5 months, the median overall survival in the entire iNHL population was 18.4 months and the median PFS was 8.4 months.

The FDA is scheduled under the Prescription Drug User Fee Act to make its decision by October 5, 2018.

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In hepatocellular carcinoma, ramucirumab extended overall survival versus placebo as a second-line treatment for patients with elevated baseline alpha-fetoprotein, according to findings from the phase III REACH-2 trial.

Aside from the primary OS endpoint, ramucirumab also improved progression-free survival. Eli Lilly and Company, the manufacturer of the VEGFR-2 inhibitor, plan to present findings from the study at an upcoming medical meeting.

REACH-2 is a follow-up to the phase III REACH trial, which showed that second-line treatment with ramucirumab did not improve OS versus placebo in the full population of patients with advanced HCC.

In the full population of the study, the median OS was 9.2 months with ramucirumab compared with 7.6 months with placebo. The numerical difference of 1.6 months between the two arms did not cross the barrier for statistical significant.

Further analysis of REACH showed that patients with high expression of AFP did experience an OS benefit with ramucirumab. Based on these data, the phase III REACH-2 study was launched, with the goal of assessing ramucirumab specifically in patients with AFP-high HCC.

Ramucirumab currently is approved by the FDA in lung cancer, colorectal cancer, and gastric or gastroesophageal junction adenocarcinoma.

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This week, we sat down with Dr John Marshall of Georgetown Lombardi Comprehensive Cancer Center, to discuss treatment beyond the second-line setting for patients with pancreatic cancer.

That’s all for today.

Thank you for watching OncLive News Network! I’m Gina Columbus.