publication date: Oct. 30, 2014
20141030 - Oct. 30, 2014
October 2014PDF

 Lung Cancer

Gilotrif Increases PFS Compared to Erlotinib In LUX-Lung 8 Phase III Head-to-Head Trial


Phase III data from the LUX-Lung 8 head-to-head trial, evaluating Gilotrif versus erlotinib in patients with advanced squamous cell carcinoma of the lung, demonstrated superior improvement in progression-free survival with Gilotrif.

The trial demonstrated that Gilotrif (afatinib) significantly reduced the risk of disease progression by 18 percent when compared to erlotinib and delayed tumor growth (PFS by independent review: 2.4 vs. 1.9 months; HR=0.82; p=0.043). Overall survival data are not yet mature.

Treatment with Gilotrif showed improvement in the secondary endpoint of disease control rate compared to erlotinib, 45.7 vs. 36.8 percent, respectively (p=0.020). Objective response rate was 4.8 percent in the Gilotrif arm compared to 3.0 percent in the erlotinib arm (p=0.233). 

 Melanoma

Cobimetinib-Zelboraf Therapy Increases OS In BRAF V600 Mutation-Positive Disease

A phase III trial showed that people with previously untreated BRAF V600 mutation-positive advanced melanoma who received the MEK inhibitor cobimetinib plus Zelboraf (vemurafenib) lived significantly longer without their disease worsening or death compared to Zelboraf alone.

The combined therapy reduced the risk of disease worsening or death by half (HR=0.51, 95% CI 0.39-0.68; p<0.0001), with a median PFS of 9.9 months for cobimetinib plus Zelboraf compared to 6.2 months with Zelboraf alone. 

 Prostate Cancer

Zytiga and Prednisone Extends Overall Survival in mCRPC Trial

A final analysis of a phase III trial showed that Zytiga (abiraterone acetate) plus prednisone significantly prolonged overall survival compared to an active control of placebo plus prednisone, in men with chemotherapy-naïve metastatic castration-resistant prostate cancer.

The study demonstrated a 19 percent reduction in risk of death in this study population, with a median OS of 34.7 compared to 30.3 months respectively (HR= 0.81 [95% CI, 0.70-0.93]; p = 0.0033), after a median follow-up of more than four years (49.2 months).

 Thyroid Cancer
Study: Angiopoietin-2 Levels May Predict Lenvatinib Response
 Head and Neck Cancer
Afatinib Delays Tumor Growth In LUX-Head and Neck 1 Study
 Cachexia
Anamorelin Increases Body Mass In Two Global Phase III Trials
 NCI CTEP-Approved Trials for the Month of October
 Drugs and Targets

  • Velcade Injection approved in Mantle Cell Lymphoma

  • Akynzeo approved for nausea and vomiting following chemotherapy

  • European Commission approves Imbruvica in MCL and CLL

  • CMS publishes two draft local coverage determinations for prostate cancer tests

  • FDA grants aldoxorubicin orphan drug designations in three indications

  • Blinatumomab granted priority review in ALL

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