Indianapolis-based Eli Lilly and Co. (NYSE: LLY) says a potential lung cancer treatment has “demonstrated significant survival improvement” in a late-stage trial. Ramucirumab, also known as CYRAMZA, has already been approved in the U.S. for advanced gastric cancer patients. Reuters reports investment bank Cowen and Co. believes the drug could be a blockbuster.

It predicts annual sales could hit $1.2 billion in the next six years.

News Release

CHICAGO, Ill. – Eli Lilly and Company (NYSE: LLY) today announced detailed results from REVEL, a global Phase III study of CYRAMZA (ramucirumab) in combination with chemotherapy in patients with second-line non-small cell lung cancer (NSCLC). Data from the trial were published today in The Lancet and also presented at the American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #LBA8006). REVEL is the first positive Phase III study of a biologic in combination with chemotherapy to demonstrate improved overall survival compared to chemotherapy alone in second-line NSCLC.

Lung cancer is the leading cause of cancer death in the U.S. and most other countries, and non-small cell lung cancer accounts for 85 percent of all lung cancer cases. It is estimated that approximately half of NSCLC patients are receiving treatment in the second-line setting. Despite currently available therapies, there continues to be a need for new second-line treatment options for patients with NSCLC.

“While there have been other recent Phase III studies that have evaluated the addition of a cytotoxic or targeted agent in previously-treated NSCLC patient populations, none have demonstrated improved overall survival in the total patient population,” said Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology. “We are pleased that CYRAMZA demonstrated a significant survival improvement in a difficult-to-treat patient population where there continues to be a major unmet medical need in both nonsquamous and squamous NSCLC patients. These data build on Lilly's continued commitment to discovering potential new treatment options for the large numbers of people fighting lung cancer. They also add to our growing clinical data set for CYRAMZA, which is being studied in multiple tumor types.”

The global, randomized, double-blind REVEL trial compared CYRAMZA plus docetaxel to placebo plus docetaxel in NSCLC patients with progression after platinum-based chemotherapy for locally-advanced or metastatic disease. The international study included a total of 1,253 nonsquamous and squamous NSCLC patients from 26 countries on six continents. Overall survival (OS) was the trial's primary endpoint and secondary endpoints included progression-free survival (PFS) and objective response rate (ORR).

Patients treated on the CYRAMZA-plus-docetaxel arm (n=628) achieved a median OS of 10.5 months compared to 9.1 months for patients on the placebo-plus-docetaxel arm (n=625). The OS hazard ratio was 0.86 (95% CI, 0.751-0.979, p=0.023), which corresponds to a 14 percent reduction in risk of death.

Median PFS was 4.5 months on the CYRAMZA-plus-docetaxel arm compared to 3.0 months on the placebo-plus-docetaxel arm, with a PFS hazard ratio of 0.76 (p < 0.001),="" which="" corresponds="" to="" a="" 24="" percent="" reduction="" in="" risk="" of="" progression="" or="" death.="" orr="" was="" 23="" percent="" on="" the="" cyramza-plus-docetaxel="" arm="" and="" 14="" percent="" on="" the="" placebo-plus-docetaxel="" arm="" (p=""><>

“In the REVEL study, CYRAMZA demonstrated statistically significant improvement across multiple efficacy endpoints including overall survival, progression-free survival and overall response rate. The improvement of overall survival and progression-free survival on the CYRAMZA-plus-docetaxel arm was also consistent across the majority of subgroups including histology,” said Maurice Perol, M.D., of the Leon-Berard Cancer Centre in France and co-lead investigator of the REVEL study. “Overall, these results are very encouraging for those of us who treat lung cancer patients.”

The most common ( > 5% incidence) Grade > /=3 adverse events occurring more frequently in patients on the CYRAMZA arm were neutropenia (48.8% vs. 39.8%), febrile neutropenia (15.9% vs. 10.0%), fatigue (14.0% vs 10.5%), leukopenia (13.7% vs. 12.5%), and hypertension (5.6% vs. 2.1%). Grade 5 adverse events were comparable between arms (5.4% vs. 5.8%). Patients on the CYRAMZA arm experienced more bleeding/hemorrhage events (all grade) (28.9 % vs 15.2%) but the rate of Grade > /=3 bleeding / hemorrhage events were similar between arms (2.4% vs 2.3%).

Dr. Perol presented the REVEL data at ASCO and Edward Garon, M.D., director of the Thoracic Oncology Program at the David Geffen School of Medicine at UCLA / Translational Oncology Research Laboratory and co-lead investigator of the REVEL study, is the lead author in The Lancet publication of the data.

Lilly intends to submit the first application of these data to regulatory authorities in the second half of 2014.

About the REVEL Trial

REVEL was a global, randomized, double-blind Phase III study of ramucirumab plus docetaxel compared to placebo plus docetaxel in NSCLC patients with progression after prior platinum-based chemotherapy for locally-advanced or metastatic disease. Initiated in 2010, the global study enrolled 1,253 patients across 26 countries on six continents. The primary endpoint (also referred to as the major efficacy outcome measure) of the REVEL trial was overall survival and secondary endpoints (also referred to as the supportive efficacy outcome measures) included: progression-free survival; objective response rate; quality of life; and safety. The study included nonsquamous and squamous NSCLC patients.

About Lung Cancer

Lung cancer is the leading cause of cancer death in the U.S. and most other countries, killing nearly 1.6 million people worldwide each year.[1] In the U.S., lung cancer is responsible for nearly 30 percent of all cancer deaths, more than those from breast, colon and prostate cancers combined.[2] Stage IV NSCLC is a very difficult-to-treat cancer and the prognosis for patients with NSCLC is poor when locally advanced or metastatic.[3] NSCLC is much more common than other types of lung cancer, and accounts for 85 percent of all lung cancer cases. Patients with squamous cell carcinoma represent about 30 percent of all patients affected by NSCLC, while non-squamous patients represent about 70 percent.[4] It is estimated that approximately half of NSCLC patients are receiving treatment in the second-line setting.[5]

About Angiogenesis

Angiogenesis is the process of making new blood vessels. This process involves the migration, growth, and differentiation of endothelial cells, which line the inside wall of blood vessels. Chemical signals in the body stimulate the repair of damaged blood vessels and formation of new blood vessels during this process.

In a person with cancer, angiogenesis creates new blood vessels that give a tumor its own blood supply, allowing it to grow and spread.

Some tumors create proteins called VEGF. These proteins attach to the VEGF receptors of blood vessel cells causing new blood vessels to form around the tumors, enabling growth. Blocking the VEGF protein from linking to the blood vessels helps to inhibit tumor growth by slowing angiogenesis and the blood supply that feeds tumors.

Of the three known VEGF receptors, VEGF Receptor 2 is linked most closely to VEGF-induced tumor angiogenesis.[6]

About CYRAMZA™ (ramucirumab)

CYRAMZA as a single agent is approved for patients with advanced gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma who have progressed after prior fluoropyrimidine- or platinum-containing chemotherapy. CYRAMZA inhibited angiogenesis in an in vivo animal model. CYRAMZA is a VEGF Receptor 2 antagonist that specifically binds and blocks activation of VEGF Receptor 2 and blocks binding of VEGF receptor ligands VE

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