A global Phase III study (REVEL) of ramucirumab in combination with chemotherapy in patients with second-line non-small cell lung cancer (NSCLC), showed a statistically significant improvement in the primary endpoint of overall survival in the ramucirumab-plus-docetaxel arm compared to the control arm of placebo plus docetaxel (Press release Eli Lilly, FEB 19, 2014, View Source [SID:1234500091]). REVEL also showed a statistically significant improvement in progression-free survival in the ramucirumab arm compared to the control arm.
The global, randomized, double-blind REVEL trial compared ramucirumab and docetaxel to placebo and docetaxel in NSCLC patients whose disease has progressed after failure of prior platinum-based chemotherapy for locally advanced or metastatic disease. The study included nonsquamous and squamous NSCLC patients. The most common ( > 5% incidence) Grade > 3 adverse events occurring at a higher rate on the ramucirumab-plus-docetaxel arm compared to the control arm were decreased white blood cell count (neutropenia/leukopenia), febrile neutropenia, fatigue/asthenia and hypertension.
Lilly plans to present data from the REVEL trial at an upcoming scientific meeting and intends to submit the first application of these data to regulatory authorities in 2014.

On February 19, 2014 Novartis announced that the pivotal trial of LDE225 (sonidegib) in advanced basal cell carcinoma met its primary endpoint of demonstrating an objective response rate among patients within six months of treatment (Press release Novartis, FEB 18, 2014, View Source [SID:1234500094]). Objective response included complete response (clinically significant tumor response with complete absence of disease) and partial response (clinically significant tumor shrinkage).
Full study results will be presented at a future scientific meeting.

On February 17, 2014 Cellectis announced that it has signed a strategic collaboration agreement with Servier (Press release Cellectis, FEB 17, 2014, View Source [SID:1234500089]).
The partnership covers the development and potentially the commercialization of Cellectis’ lead product candidate, UCART19. Engineered allogeneic CD19 T-cells currently stand out as a real therapeutic innovation for treating various types of leukemias and lymphomas.
The agreement also included research, development, and potentially the commercialization of five other product candidates targeting solid tumors.
Cellectis will be responsible for the R&D of certain product candidates through the end of Phase I. Servier may exercise an exclusive worldwide option for a license on each product candidate developed under the agreement. Upon exercising each option, Servier will be responsible for taking over clinical development, registration and commercialization of each product.
The financial terms of the collaboration include an upfront payment of $10 million and up to $140 million for each of the six product candidates potentially developed, spread over various milestones in the development and commercialization phases. In addition, Cellectis will receive royalties on the sales of commercialized products.

On February 17, 2014 Novartis announced the acquisition of CoStim Pharmaceuticals Inc., a Cambridge, MA-based, privately held biotechnology company focused on harnessing the immune system to eliminate immune-blocking signals from cancer (Press release Novartis, FEB 17, 2014, View Source [SID:1234500084]). With this acquisition Novartis is adding late discovery stage immunotherapy programs directed to several targets, including PD-1.
Financial terms are not disclosed.