Priority Reviews and Breakthroughs in Top Cancer News


Recent advances and updates in oncology and cancer drug development.

Afatinib Approved for Squamous Lung Cancer

The FDA approved afatinib for the treatment of patients with advanced squamous cell non—small cell lung cancer following progression on platinum-based chemotherapy. The approval was based on results from the phase III LUX-Lung 8 study, which compared second-line afatinib with erlotinib in patients with advanced squamous cell carcinoma of the lung. In the study, afatinib reduced the risk of death by 19% and disease progression by 18% compared with erlotinib.

OS was 7.9 months versus 6.8 months with afatinib versus erlotinib, respectively (HR, 0.81; 95% CI, 0.69-0.95; P = .0077). PFS was 2.4 months with afatinib compared to 1.9 months with erlotinib (HR, 0.82; 95% CI, 0.68-1.00; P = .0427). The objective response rates were similar between the 2 arms, at 6% and 11%, respectively (P = .0551). More patients reported improved overall health-related quality-of-life with afatinib than erlotinib (36% vs 28%).

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Nivolumab Granted Priority Review for Hodgkin Lymphoma

The FDA has granted nivolumab a priority review for use in previously treated patients with classical Hodgkin lymphoma, giving the drug the potential to become the first PD-1 inhibitor approved for a hematologic malignancy. The supplemental biologics license application was submitted by Bristol-Myers Squibb under a 2014 breakthrough therapy designation that nivolumab received for the treatment of patients with Hodgkin lymphoma following autologous stem cell transplant and brentuximab vedotin.

Under the expedited priority review, the FDA will review the sBLA within 6 months, compared with the standard 10-month review. This places a final decision in the second half of 2016. The sBLA was primarily based on data from the CheckMate-205 trial, which is evaluating nivolumab in both newly diagnosed and previously treated patients with cHL.

Results from the study will be presented at a scientific meeting later this year, according to BMS. In prior results from a phase I study, 87% of patients experienced a response to nivolumab, including 6 complete responses.

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Pembrolizumab Nabs Breakthrough Designation for cHL

The FDA granted a breakthrough therapy designation to pembrolizumab as a treatment for patients with relapsed or refractory classical Hodgkin lymphoma. The designation was based on phase Ib data from the KEYNOTE-013 study and yet unpublished findings from the phase II KEYNOTE-087 trial. In data from the phase Ib study, pembrolizumab demonstrated an objective response rate of 64.5% in pretreated patients with cHL.

This response rate included 5 complete responses (16.1%) and 15 partial responses (48.4%). Additionally, 23% of patients experienced stable disease with pembrolizumab. After a median of 9.7 months of follow-up, median duration of response was not yet reached. Findings from KEYNOTE-087 will be presented at an upcoming medical meeting, according to Merck.

In this study, pembrolizumab was administered to patients with relapsed/refractory classical Hodgkin lymphoma at 200 mg every 3 weeks across a variety of settings. A phase III study is planned to compare pembrolizumab with brentuximab vedotin for patients with relapsed or refractory cHL.

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Pembrolizumab Granted Priority Review for Head and Neck Cancer

The FDA has granted a priority review designation to pembrolizumab as a treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma following a platinum-based chemotherapy. The application for pembrolizumab was based on updated data from the phase Ib KEYNOTE-012 trial.

In the study, the objective response rate was 23.7% in patients with HNSCC who received pembrolizumab at either 200 mg every 3 weeks or 10 mg/kg every 2 weeks. The stable disease rate by RECIST criteria was 25.4%. The application for the HNSCC indication is specifically for the 200 mg dose administered intravenously every 3 weeks.

Prior approvals for the PD-1 inhibitor have been for a 2-mg/kg dose. Under the Prescription Drug User Fee Act, the FDA is scheduled to make an approval decision by August 9, 2016.

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ODAC Calls for More Data for Rociletinib in NSCLC

ODAC voted 12-1 against the accelerated approval of rociletinib for patients with metastatic EGFR T790M­—mutated non–small cell lung cancer who have previously received an EGFR-targeted therapy. The panel was considering whether a pooled efficacy and safety analysis from the early-stage CO-1686-008 (TIGER-X) and CO-1686-019 (TIGER-2) trials was sufficient to recommend accelerated approval of the third-generation EGFR inhibitor.

With its negative vote, the panel recommended that the results of the randomized phase III CO-1686-020 trial (TIGER-3) should be submitted before the FDA makes a decision on the application. The open-label, multinational TIGER-3 trial is comparing rociletinib with single-agent chemotherapy (pemetrexed, docetaxel, or gemcitabine) in patients with EGFR-mutation positive NSCLC with disease progression following both an EGFR-TKI and platinum doublet chemotherapy. The current action date for a final FDA approval decision on rociletinib is June 28, 2016.

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EGFR Findings Intrigue at ELCC

Patients with non-small cell lung cancer who ceased to respond to EGFR TKI therapy demonstrated a rapid and robust response to the investigational agent BI-1482694 (HM61713). In the study, the objective response rate by independent assessment with BI-1482694 was 62% for patients with T790M-positive NSCLC. When looking specifically at those with a response confirmed on subsequent scans, the response rate with BI-1482694 was 46%.

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First-line treatment with single-agent osimertinib induced a response rate of 77% in patients with EGFR-mutated NSCLC. The median progression-free survival was 19.3 months for patients receiving osimertinib at 160 mg once daily (n = 30) and was not yet reached for patients receiving the third-generation EGFR TKI at a dose of 80 mg once daily (n = 30). The median duration of response was 16.7 months with 160 mg and non-calculable in the 80-mg group.

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Survival Benefit Quantified in Long-Term Nivolumab Data

Two studies at the 2016 AACR Annual Meeting demonstrated the long-term overall survival benefits of nivolumab in combination and as a single-agent for patients with metastatic melanoma. In a phase I study, single-agent nivolumab demonstrated a robust 5-year overall survival rate of 34% for heavily pretreated patients with metastatic melanoma who had not received prior ipilimumab.

This rate is roughly double the median listed in the SEER database for patients with metastatic melanoma. After a minimum follow-up of 45 months, median OS was 17.3 months across all doses and was 20.3 months at the approved 3 mg/kg dose.

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The combination of ipilimumab and nivolumab showed a 42% improvement in OS compared with ipilimumab monotherapy for patients with advanced melanoma in a 2-year assessment of the phase II CheckMate-069 trial. The 2-year OS rate with the combination was 69% compared with 53% for ipilimumab alone, for patients with BRAF wild-type melanoma.

The median OS among patients was not been reached with the combination regimen and was 24.8 months with ipilimumab monotherapy (HR, 0.58, 95% CI, 0.31-1.08). In the overall study population, the 2-year OS rate was 64% with the combination compared with 54% for ipilimumab alone (HR, 0.74; 95% CI, 0.43-1.26).

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MammaPrint Validated in Phase III Study

MammaPrint demonstrated a high level of accuracy at identifying a large subset of women with clinically high-risk early stage breast cancer for whom adjuvant chemotherapy was unlikely to produce benefit, according to findings from the phase III MINDACT study presented at the 2015 AACR Annual Meeting. The rate of 5-year distant metastasis-free survival in women who were clinically high risk/genomically low risk and randomized to no chemotherapy was the primary statistical test for MINDACT.

In this group, in which 48% of the women had positive nodes, the 5-year DMFS was 94.7% (95% CI, 92.5%-96.2%), which passed the bar for significance of 92%. Utilization of the MammaPrint test could result in a reduction in overtreatment for patients with early-stage breast cancer. Findings from the MINDACT study represent the first level 1A evidence for a risk assessment tool.

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