Full Press Release Details
June 05, 2004
New interim data show metastatic breast cancer patients experienced a promising improvement in survival when treated with a Gemzar ® /Taxol ® combination compared to patients treated with Taxol alone, a current standard of care in this patient population.
"The analysis strongly favors the Gemzar plus Taxol combination and represents a new standard for the frontline treatment of women in metastatic breast cancer," said Kathy Albain, M.D., lead author of the study and professor of medicine, Loyola University Chicago, Cardinal Bernardin Cancer Center.
Albain presented her Phase III study data today at the annual meeting of the American Society of Clinical Oncology (ASCO). Albain's study concludes:
• The Gemzar/Taxol combination is a new therapy that provides superior outcomes over therapy with single-agent Taxol.
• The Gemzar/Taxol combination should also be studied in the primary breast cancer setting, as it is very well-tolerated by patients.
• The Gemzar/Taxol results in very promising overall survival compared to Taxol.
On May 19, 2004, the U.S. Food and Drug Administration (FDA) approved Eli Lilly's Gemzar in combination with Taxol for the treatment of metastatic breast cancer, providing the drug with its third U.S. indication (Gemzar is also approved for the treatment of metastatic pancreatic cancer and, in combination with cisplatin, for the treatment of advanced non-small cell lung cancer).
The FDA's approval in metastatic breast cancer was based on time to disease progression and the interim survival results evidenced in this study. Survival results will continue to be gathered until early 2005.
Results from the randomized phase III study showed a median overall survival of 18.5 months for patients on the Gemzar/Taxol combination compared to 15.8 months for patients who received single-agent Taxol.
Additionally, patients on the Gemzar/Taxol combination experienced significant improvements in response rate (40.8 percent for Gemzar/Taxol vs. 22.1 percent for Taxol) and time to disease progression (5.2 months Gemzar/Taxol vs. 2.9 months for Taxol). Patients on the Gemzar/Taxol combination did experience higher rates of hair loss, neutropenia (a lowering of the white blood cell count), and fatigue.
"This is welcome news to patients and physicians," said Paolo Paoletti, M.D., vice president of oncology clinical research at Eli Lilly and Company. (NYSE:LLY) "Metastatic breast cancer is a disease marked by high recurrence rates and the Gemzar/Taxol combination certainly represents a treatment benefit for patients in that setting."
Paoletti said the study results could also mark a shift in the standard method of treatment for metastatic breast cancer patients. Patients are normally treated with a single-agent because when two drugs are administered conjunctively, the combined side effects are sometimes too great for the patient to handle. "The Gemzar/Taxol combination is one of the few combinations to surpass the single-agent efficacy of Taxol, and to do so with manageable side effects," said Paoletti. "Clearly, the Gemzar/Taxol combination is positive news for patients in this setting, where every treatment advance is crucial."
More About the Study
The randomized phase III study included 98 cancer study centers and encompassed 19 countries.
The 529-patient population consisted of women whose breast cancer advanced beyond the primary phase after receiving prior adjuvant chemotherapy that was anthracycline based unless otherwise contraindicated. The Gemzar/Taxol combination was administered to 267 women and 262 received single agent Taxol.
Primary endpoints of the study were overall survival and time to disease progression. Secondary endpoints were pain, progression-free survival, analgesic use, and quality of life.
About Gemzar
Gemzar is a registered trademark of Eli Lilly Company and is approved in more than 90 countries. It is the standard of care worldwide for pancreatic cancer. Gemzar is also a standard of care in many parts of the world for non-small-cell lung and bladder cancers, and has been approved in the U.S. and many European countries as a combination therapy with paclitaxel for metastatic breast cancer. Gemzar is recently approved in several countries outside the U.S. in recurrent platinum-sensitive ovarian cancer. Gemzar is a nucleoside analogue that interferes with the processes of DNA production; by doing so, Gemzar prevents cancer cells from replicating and thus slows or stops tumour growth.
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Indiana, Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs. Additional, information about Lilly is available at www.lilly.com .
This news release contains forward-looking statements that reflect management’s current beliefs about Gemzar/Taxol combination therapy in the treatment of metastatic breast cancer. However, there are no guarantees that later studies will confirm these interim findings or that the combination therapy will prove to be commercially successful. For additional information about the factors that affect the company’s business, see the company’s Form 10-K and 10-Q filings with the United States Securities and Exchange Commission. The company undertakes no duty to update forward-looking statements.
Gemzar ® (gemcitabine hydrochloride, Lilly)
Taxol ® (paclitaxel, Bristol-Meyers Squibb, Lilly)
Gemzar