Lilly studies try to shed light on impact of race

June 1, 2007

Statistics show lung cancer is the leading cause of cancer death in African-Americans, with 21,550 new cases expected to be diagnosed and 16,700 deaths expected this year. Equally devastating, lung cancer is the leading cause of cancer death in Hispanic men and the second leading cause of cancer death in Hispanic women. Researchers at Eli Lilly and Company are actively investigating the efficacy and safety of lung cancer treatments ALIMTA® (pemetrexed for injection) and GEMZAR® (gemcitabine HCl for injection) in treating non-small cell lung cancer (NSCLC) in African-Americans, Hispanics and other diverse populations.

Two retrospective Lilly studies were unveiled today at the 43rd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Ill. They offered cursory insight into how a diverse group of patients respond to treatment with Lilly chemotherapeutic options. One study analyzed data of chemonaïve African-American patients with stage IIIB/IV NSCLC treated with GEMZAR in combination with carboplatin or paclitaxel (Taxol®) versus patients taking carboplatin in combination with paclitaxel. The second study provided data from six previous trials for non-Caucasian patients with advanced or metastatic NSCLC treated with ALIMTA.

“African-Americans are often underrepresented in clinical trials and, therefore, little is known about the possible impact of race on the utility of many medications,” said Coleman Obasaju, M.D., Ph.D., United States oncology medical director of Lilly and the principal investigator of these two studies. “Because lung cancer is a particularly devastating disease, and a growing concern in the African-American population, it was a logical starting point for our analysis.”

The GEMZAR study released at ASCO analyzed overall survival data from a previous randomized Phase III trial in the treatment of NSCLC, viewing data outcomes and toxicity data of 128 African-Americans compared with 906 Caucasians. The trial was designed to compare the efficacy of GEMZAR plus carboplatin with GEMZAR plus paclitaxel and a reference regimen of carboplatin plus paclitaxel. Data from all three arms were pooled for this analysis. Overall survival, the primary endpoint, on the African-American arm was 8.7 months compared to 8.1 months in the Caucasian arm, which was not significantly different. African-Americans demonstrated slightly lower incidences of grade 3/4 toxicities (constitutional, hemorrhagic and metabolic).

The ALIMTA study reviewed a post-hoc analysis of pooled data from six previous trials, including one Phase III in a second-line setting and five Phase II trials in a first-line setting. Patients with Stage IIIB/IV NSCLC were given at least one dose of ALIMTA (single-agent or in combination with other treatments) every 21 days. The trial evaluated results from 411 Caucasian patients compared with 117 non-Caucasian (African-American, Asian and Hispanic) patients. Based on this analysis, race did not have a statistically significant impact on efficacy parameters (response rate, survival and disease control rate). Non-Caucasian patients had lower grade 3/4 toxicities, including neutropenia (a decrease in white blood cells); anemia (a decrease in red blood cells); fatigue; and nausea.

“At the very least, the data unveiled today suggests that we should continue actively studying the impact of our medications on a diverse number of populations,” said Dr. Obasaju.

To that end, Lilly recently began enrollment into what may be the largest and most diverse Phase III study in NSCLC. The study will evaluate ALIMTA in 1,000 patients with NSCLC. Enrollment will include 200 African-Americans, 200 Asians, 200 Hispanics and 400 Caucasians. For more information on this trial visit or

“Scientific reasoning tells us that because of genetic differences, patients with similar tumors may respond differently to specific treatment regimens,” said Richard Gaynor, M.D., vice president, cancer research and global oncology platform leader at Lilly. “Ultimately, our goal is to ensure that we offer the optimal outcome to each and every patient.”

Source: CPR Worldwide

Explore further: US jury hits Takeda, Eli Lilly with $9B penalty (Update)

Related Stories

US jury hits Takeda, Eli Lilly with $9B penalty (Update)

April 8, 2014
A U.S. jury ordered Japanese drugmaker Takeda Pharmaceutical Co. and its U.S. counterpart, Eli Lilly and Co., to pay $9 billion in punitive damages over a diabetes medicine linked to cancer. The drug companies said Tuesday ...

British court ruling backs patent protecting Lilly's Alimta

June 25, 2015
Eli Lilly received some European legal backing for its top product, the lung cancer treatment Alimta, on Thursday when a British court upheld a patent protecting a vitamin regimen administered with the drug.

FDA approves Eli Lilly's injectable diabetes drug

September 18, 2014
The Food and Drug Administration has approved a new injectable diabetes drug from Eli Lilly and Co. for adults with the most common form of the disease.

NIH and Lilly to generate public resource of approved and investigational medicines

March 13, 2012
The National Institutes of Health and Eli Lilly and Company will generate a publicly available resource to profile the effects of thousands of approved and investigational medicines in a variety of sophisticated disease-relevant ...

Boston lawsuit claims DES-breast cancer link

January 8, 2012
(AP) -- Arline MacCormack first heard about DES from her mother when she was 17. Three decades later, MacCormack believes that the drug her mother took to prevent miscarriages caused her to develop breast cancer at age 44.

Combining new and old drugs improves survival for soft-tissue cancer patients

July 20, 2016
Adding a novel monoclonal antibody therapy to traditional chemotherapy increased median survival by nearly a year in patients with advanced sarcoma, a lethal soft-tissue cancer. Findings from a multicenter clinical trial ...

Recommended for you

Combination immunotherapy targets cancer resistance

November 22, 2017
Cancer immunotherapy drugs have had notable but limited success because in many cases, tumors develop resistance to treatment. But researchers at Yale and Stanford have identified an experimental antibody that overcomes this ...

Researchers discover specific tumor environment that triggers cells to metastasize

November 21, 2017
A team of bioengineers and bioinformaticians at the University of California San Diego have discovered how the environment surrounding a tumor can trigger metastatic behavior in cancer cells. Specifically, when tumor cells ...

New study points the way to therapy for rare cancer that targets the young

November 21, 2017
After years of rigorous research, a team of scientists has identified the genetic engine that drives a rare form of liver cancer. The findings offer prime targets for drugs to treat the usually lethal disease, fibrolamellar ...

Clinical trial suggests new cell therapy for relapsed leukemia patients

November 20, 2017
A significant proportion of children and young adults with treatment-resistant B-cell leukemia who participated in a small study achieved remission with the help of a new form of gene therapy, according to researchers at ...

Cell-weighing method could help doctors choose cancer drugs

November 20, 2017
Doctors have many drugs available to treat multiple myeloma, a type of blood cancer. However, there is no way to predict, by genetic markers or other means, how a patient will respond to a particular drug. This can lead to ...

Researchers discover a new target for 'triple-negative' breast cancer

November 20, 2017
So-called "triple-negative" breast cancer is a particularly aggressive and difficult-to-treat form. It accounts for only about 10 percent of breast cancer cases, but is responsible for about 25 percent of breast cancer fatalities.


Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.