Priority Review to Head and Neck Cancer Drug in Top Oncology News

Recent advances and updates in oncology and cancer drug development.

FDA Grants Nivolumab Priority Review for Head and Neck Cancer

The FDA has granted a priority review designation to nivolumab as a treatment for patients with previously treated metastatic or recurrent squamous cell carcinoma of the head and neck, based on findings from the CheckMate-141 study.

In the phase III study, the median overall survival with nivolumab was 7.5 months compared with 5.1 months with investigator's choice (HR, 0.70; P = .0101). The 1-year OS rates were 36% with nivolumab compared with 16.6% for investigator’s choice. The objective response rate was 13.3% with nivolumab and 5.8% for investigator's choice. The ORR in the nivolumab arm consisted of 6 complete responses (2.5%) and the stable disease rate was 22.9%. In the investigator's choice arm, 1 patient had a complete response and the SD rate was 35.5%.

The median progression-free survival was 2.0 months with nivolumab versus 2.3 months with investigator's choice (HR, 0.89; P = .3236). The 6-year PFS rates were 19.7% for nivolumab and 9.9% for investigator's choice of therapy. The FDA is scheduled to make a decision on the application for the PD-1 inhibitor by November 11, 2016, as part of the Prescription Drug User Fee Act.

See more http://www.onclive.com/web-exclusives/fda-grants-nivolumab-priority-review-for-head-and-neck-cancer

LOXO-101 Gets Breakthrough Designation for Solid Tumors

The FDA granted the selective TRK inhibitor LOXO-101 a breakthrough therapy designation for the treatment of adult or pediatric patients with unresectable or NTRK-positive metastatic solid tumors who progressed on prior therapy or have no other available treatment options. The designation, which will expedite the development and review of LOXO-101, is based on 3 early stage trials. Available data from across the studies showed that 6 of 7 evaluable patients receiving LOXO-101 had a confirmed partial response.

Among the 6 patients, 5 had confirmed partial responses (RECIST), and the sixth patient demonstrated a tumor regression of 21%. The study authors noted that objective antitumor activity had not been observed in patients without an NTRK fusion. The second study was a single-patient case study of LOXO-101 in with infantile fibrosarcoma with NTRK3—ETV6 fusion, in which the agent showed activity.

The third study was a global phase II basket trial that is still enrolling patients aged ≥18 years with advanced solid tumors and primary CNS malignancies harboring TRK gene fusions. Results from this study are expected in the second half of 2016.

See more: http://www.onclive.com/web-exclusives/fda-grants-loxo101-breakthrough-designation-for-solid-tumors

Osimertinib Passes Phase III Test

The phase III AURA3 study has confirmed the benefits of osimertinib seen in phase II studies for patients with EGFR T790M-mutant locally-advanced or metastatic non—small cell lung cancer who progressed on a frontline EGFR TKI. In the phase III study, osimertinib demonstrated a significant improvement in progression-free survival compared with standard platinum-based chemotherapy.

Additionally, secondary endpoints of objective response rate, disease control rate, and duration of response were also improved with osimertinib versus chemotherapy. Further analyses of the study are ongoing, specifically for overall survival, according to AstraZeneca. The company plans to present results from the AURA3 trial at an upcoming medical meeting. Findings from the phase III trial will serve as confirmatory findings for an accelerated FDA approval received by osimertinib in November 2015.

See more http://www.onclive.com/web-exclusives/osimertinib-extends-pfs-in-phase-iii-study-for-t790mmutant-nsclc

FDA Approves New Version of Optune for GBM

The FDA has approved a smaller and lighter version of Optune for patients with glioblastoma multiforme. The first-generation of Optune was most recently approved in 2015 for use in combination with adjuvant temozolomide as a treatment for patients with newly diagnosed GBM following surgery, chemotherapy, and radiation therapy. Optune was initially approved in 2011 for the treatment of recurrent GBM after other surgical and radiation options were exhausted.

The new version of Optune, which is carried by the patient throughout their daily activities, weighs 2.7 pounds and is easier to transport. The previous version weighed 6 pounds. Patients using the first-generation of the device will be given the opportunity to switch to the newly approved version within the next few weeks.

See more http://www.onclive.com/web-exclusives/fda-approves-new-version-of-optune-for-gbm

Obinutuzumab Not Better Than Rituximab in DLBCL

Adding obinutuzumab to the CHOP chemotherapy regimen (G-CHOP) in the frontline setting did not improve progression-free survival compared with the standard regimen of rituximab plus CHOP (R-CHOP) in patients with diffuse large B-cell lymphoma, according to results from the phase III GOYA trial. The safety profiles for obinutuzumab and rituximab were similar to previously reported adverse event data for the 2 agents.

Complete data from the GOYA study will be presented at an upcoming scientific meeting, the company reported. Obinutuzumab had previously shown superiority to rituximab in 2 phase III studies. The first study to directly compare obinutuzumab with rituximab was the CLL11 trial, in which obinutuzumab plus chlorambucil reduced the risk of disease progression by 58% compared with rituximab plus chlorambucil in previously untreated patients with chronic lymphocytic leukemia.

The phase III GALLIUM study was the second trial to show superior PFS outcomes with frontline obinutuzumab plus chemotherapy versus rituximab plus chemotherapy. This study looked at the agents as treatments for patients with follicular lymphoma. Results from this study have not yet been announced.

See more http://www.onclive.com/web-exclusives/obinutuzumab-falls-short-in-phase-iii-dlbcl-trial

Lenalidomide Approved in Europe for MCL

The European Commission has approved lenalidomide for use as a treatment for patients with relapsed or refractory mantle cell lymphoma. The approval was based on data from the phase II MCL-002 trial in which lenalidomide reduced the risk of progression or death by 39% versus investigator's choice of therapy. The median progression-free survival was 8.7 months with lenalidomide versus 5.2 months in the investigator’s choice arm (HR, 0.61; P = .004).

The objective response rate was 40% in the lenalidomide cohort versus 11% in patients treated with investigator's choice. Additionally, 5% of patients in the lenalidomide arm experienced a complete response versus 0% in the investigator's choice arm. Median duration of response was 16.1 months with lenalidomide versus 10.4 months in the investigator's choice cohort. The EC decision follows a positive opinion issued by the European Medicines Agency’s Committee for Medicinal Products for Human Use.

See more http://www.onclive.com/web-exclusives/ec-approves-lenalidomide-for-relapsedrefractory-mantle-cell-lymphoma

Aldoxorubicin Flops in Phase III Sarcoma Study

Treatment with aldoxorubicin failed to improve progression-free survival compared with investigator's choice of therapy for patients with advanced soft tissue sarcoma. The analysis, which was conducted after 191 progression events, showed a median PFS of 4.17 months with aldoxorubicin compared with 4.04 months with investigator's choice of therapy, which included doxorubicin or pazopanib (HR, 0.91).

Findings were not yet announced for secondary endpoints, with follow up still ongoing for overall survival. Patients treated with aldoxorubicin experienced an improvement in ORR compared with investigator's choice that was described as a “doubling in response,” although the statistical significance of this improvement was not announced. The disease control rate was also improved versus investigator's choice (P = .048). Aldoxorubicin-related adverse events were consistent with prior studies. Full results are expected at an upcoming meeting, with findings from a second analysis anticipated in the fourth quarter of 2016.

See more http://www.onclive.com/web-exclusives/aldoxorubicin-misses-primary-endpoint-in-phase-iii-sarcoma-study