Eli Lilly's Cyramza 'REVELs' in Phase III


Eli Lilly and Company’s (LLY) Cyramza (ramucirumab) showed improved overall survival rate compared to chemotherapy alone in patients suffering from second-line non-small cell lung cancer (:NSCLC) in a global phase III study (:REVEL). The company announced detailed results from the REVEL study (n=1253) at the American Society of Clinical Oncology (TATD) Annual Meeting.

The randomized, double-blind study compared the combination of Cyramza and Sanofi’s (SNY) Taxotere (docetaxel) to Taxotere and placebo in second-line nonsquamous and squamous NSCLC patients whose disease progressed after platinum-based chemotherapy for locally-advanced or metastatic disease.

In this study, Cyramza showed a statistically significant improvement across multiple efficacy endpoints including overall survival, progression-free survival and overall response rate. Patients treated with Cyramza plus Taxotere showed nearly 14% and 24% reduction in risk of death and risk of progression or death, respectively.

We remind investors that Eli Lilly had first announced positive data from the phase III REVEL study on Cyramza in Feb 2014.

Eli Lilly plans to submit regulatory applications for Cyramza based on data from the REVEL study in the second half of 2014.

We note that Cyramza is already approved as a single-agent treatment for patients suffering from advanced or metastatic gastric cancer or gastroesophageal junction (:GEJ) adenocarcinoma with disease progression following prior fluoropyrimidine- or platinum-containing chemotherapy. The drug has orphan drug status in the U.S. for this indication.

Eli Lilly is also evaluating Cyramza for other types of cancer including liver and colorectal cancer. Eli Lilly intends to file for approval of Cyramza in combination with Taxol for patients suffering from gastric cancer in 2014.

Our Take

The biggest near-term challenge for Eli Lilly is to replace the revenues lost due to the genericization of Zyprexa, Cymbalta and Evista. We are encouraged by the positive data from the REVEL study on Cyramza. Cyramza’s approval for additional indications will boost Eli Lilly’s revenues.

Eli Lilly carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Allergan Inc. (AGN) and ANI Pharmaceuticals, Inc. (ANIP). Both stocks carry a Zacks Rank #1 (Strong Buy).

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