Investor Update
Basel, 9 June 2004
OSI
Pharmaceuticals summarizes survival
benefits in key patient subsets from the BR.21 study
During
the analyst
briefing on Monday 7th, an error with regards to survival benefit in patient subsets was presented.
This was amended yesterday, and full details of the data can be found below in OSI’s press release.
For further details, please refer to http://ir.roche.com for a copy of the slides
presented
yesterday morning at the OSI analyst event. We apologize for any inconvenience
caused.
On Tuesday, 8 June 2004 OSI Pharmaceuticals,
Inc. (NASDAQ: OSIP) announced a summary of data presented earlier at the 40th Annual Meeting of the
American Society of Clinical Oncology (ASCO) summarizing the treatment benefit observed in various subsets
of patients treated with the investigational drug Tarceva (erlotinib HCl) in the BR.21 study. The
study, presented on Monday, June 7, was a Phase III trial of Tarceva versus placebo in second and third-line
patients with relapsed non-small cell lung cancer.
“The results of the
BR.21 trial were noteworthy in that they demonstrated a survival benefit in essentially all subsets
of lung cancer patients that we examined,” stated Colin Goddard, Ph.D., Chief Executive Officer of OSI
Pharmaceuticals. “Previous research on other EGFR inhibitors had suggested that any Tarceva benefit
may have been restricted to certain subsets of patients. We believe that the observation of an
improvement in survival in subsets including smokers and patients with squamous cell carcinoma is of
particular interest to the lung cancer community.”
The BR.21 trial of
Tarceva met the pre-determined primary study endpoint of improvement in overall survival and demonstrated
significant effects in all secondary endpoints including time to symptom deterioration, progression-free
survival and response rate.
Patients receiving Tarceva had a median survival
of 6.7 months compared to 4.7 months in patients who received placebo (a 42.5 percent improvement).
A hazard ratio of 0.72 and a p-value of 0.001 were determined for comparison of overall survival
(a hazard ratio (HR) of less than one indicates a reduction in the risk of death and a p-value of less
than 0.05 indicates statistical significance). In addition, 31 percent of patients receiving Tarceva
in the study were alive at one year versus 22 percent in the placebo arm (a 41 percent improvement).
As
would be expected from historical data on the relative prognosis
for survival in different subsets of lung cancer patients, patients treated with Tarceva who were female,
had tumors with adenocarcinoma histology or were never smokers lived longer than patients treated with
Tarceva who were male, had tumors with squamous cell carcinoma histology or were smokers, respectively.
However, importantly, Tarceva improved survival in essentially all subsets of patients in the
study including males, patients with squamous cell carcinoma and smokers. Data summarizing the
broad-based treatment benefit that was observed in key subsets of patients in the BR.21 study is summarized
in the table below.
Median Survival in Months | Hazard Ratio |
||
Tarceva | Placebo | ||
Never Smokers | 12.2 | 5.6 | 0.42 |
Current or Former Smokers | 5.5 | 4.6 | 0.87 |
Adenocarcinoma | 7.8 | 5.4 | 0.71 |
Squamous Cell Carcinoma | 5.6 | 3.6 | 0.67 |
Female | 8.4 | 6.2 | 0.80 |
Male | 5.7 | 4.5 | 0.76 |
Note: OSI Pharmaceuticals, Inc. statistical analysis of data from the BR.21 trial
A total of 731 patients were enrolled in BR.21, a randomized, international, double-blinded controlled study comparing the use of 150mg/day Tarceva versus placebo for the treatment of patients with advanced NSCLC following failure of first or second-line chemotherapy. The study randomized patients with a 2:1 ratio in favor of Tarceva to receive either Tarceva or placebo.
Safety
The safety profile observed for Tarceva in the study was consistent with observations made in prior Tarceva studies. Seventy-six percent of patients receiving Tarceva exhibited rash (versus 17 percent in the placebo group) and 55 percent of patients receiving Tarceva experienced diarrhea (versus 19 percent for placebo). Most of these were mild or moderate. Dose reductions occurred for rash and diarrhea only in the Tarceva arm, 12 percent and five percent respectively. In this large, placebo-controlled study, severe pulmonary events including potential cases of interstitial lung events were rare and generally equally distributed between treatment arms.
About Tarceva
Tarceva is an investigational small molecule designed to target the human epidermal growth factor receptor (HER1) pathway, which is one of the factors critical to cell growth in many cancers. HER1, also known as EGFR, is a key component of the HER signalling pathway, which plays a role in the formation and growth of numerous cancers. Tarceva is designed to inhibit the tyrosine kinase activity of the HER1 signalling pathway inside the cell, which may block tumour cell growth. Results of a Phase III trial of Tarceva in pancreatic cancer are expected during the second half of 2004. Early-stage trials of Tarceva are being conducted in other solid tumours such as ovarian, colorectal, head and neck, renal cell carcinoma, glioma and gastrointestinal cancers. Tarceva was discovered by OSI Pharmaceuticals and is being developed by a global alliance of Roche, OSI Pharmaceuticals and Genentech.
Roche in Oncology
Within the last five years the Roche Group has become the world’s leading provider of anti-cancer treatments, supportive care products and diagnostics. Its oncology business includes an unprecedented four marketed products with survival benefit: Herceptin, MabThera, Xeloda and Avastin has been launched by Genentech in the US recently, treat a range of malignancies such as breast cancer, non-Hodgkin’s lymphoma and colorectal cancer. Other key products include NeoRecormon (anaemia in various cancer settings), Bondronat (prevention of skeletal events in breast cancer and bone metastases patients, hypercalcemia of malignancy), Kytril (chemotherapy and radiotherapy-induced nausea and vomiting) and Roferon-A (leukaemia, Kaposi's sarcoma, malignant melanoma, renal cell carcinoma). Roche’s cancer medicines generated sales of more than 6 billion Swiss francs in 2003.
In a recent phase III study Tarceva met its primary endpoint of improving overall survival in patients with non-small cell lung cancer.
Roche is developing new tests, which will have a significant impact on disease management for cancer patients in the future. With a broad portfolio of tumour markers for prostate, colorectal, liver, ovarian, breast, stomach, pancreas and lung cancer, as well as a range of molecular oncology tests, we will continue to be the leaders in providing cancer focused treatments and diagnostics.
Roche Oncology has four research sites (two in the US, Germany and Japan) and four Headquarter Development sites (two in the US, UK and Switzerland).
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche is number one in the global diagnostics market, the leading supplier of pharmaceuticals for cancer and a leader in virology and transplantation. As a supplier of products and services for the prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche employs roughly 65,000 people in 150 countries. The Group has alliances and R&D agreements with numerous partners, including majority ownership interests in Genentech and Chugai.
About OSI Pharmaceuticals
OSI Pharmaceuticals is a leading biotechnology company focused on the discovery, development and commercialization of high-quality, next-generation oncology products that both extend life and improve the quality-of-life for cancer patients worldwide. OSI has a balanced pipeline of oncology drug candidates that includes both novel mechanism-based, gene-targeted therapies focused in the areas of signal transduction and apoptosis and next-generation cytotoxic chemotherapy agents. OSI’s most advanced drug candidate, Tarceva, a small-molecule inhibitor of the HER1 gene, has successfully completed Phase III clinical trials for lung cancer and is subject to an ongoing rolling submission of an NDA. OSI has a commercial presence in the U.S. oncology market where it exclusively markets Novantrone (mitoxantrone concentrate for injection) for approved oncology indications and Gelclair for the relief of pain associated with oral mucositis.
All trademarks used or mentioned in this release are legally protected.