Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : OSI Pharmaceuticals (OSIP) - formerly Oncogene -- Ignore unavailable to you. Want to Upgrade?

To: Miljenko Zuanic who wrote (146)	8/19/2002 8:25:00 PM
From: tuck	Read Replies (3) \| Respond to of 447

MZ, You're probably still on vacation, but this is an interesting point for OSI, having been halved on the day it has been announced that Iressa failed in lung cancer trial (combination with platinum based chemo). >>MELVILLE, N.Y. & SAN FRANCISCO--(BW HealthWire)--Aug. 19, 2002--OSI Pharmaceuticals (NASDAQ: OSIP - News) and Genentech (NYSE: DNA - News) announced an update and commentary on the progress of the Companies' clinical trial candidate, Tarceva(TM) (erlotinib HCl). The announcement followed the release of top-line results on a competitor's drug candidate which belongs to the same class of HER1/EGFR targeted therapies as Tarceva(TM). "Overall we continue to be pleased with the progress of our comprehensive Tarceva(TM) development program," stated Dr. Colin Goddard, Chairman and CEO of OSI. "Despite today's events, we also continue to believe that Tarceva(TM) and HER1/EGFR inhibitors in general, represent a potentially important new class of agents for the treatment of human cancer." Although both drug candidates block the EGFR pathway, there are important differences between the agents and clinical programs including structure, formulation, pharmacokinetics and Phase III design and dosing. These may all play a role in the results of the Phase III trials. The Phase III program for Tarceva(TM) was built on previously disclosed Phase II data for the drug candidate which demonstrated encouraging indications of clinical activity in three separate single agent Phase II trials in refractory or advanced cancer patients with non-small cell lung, ovarian or squamous cell carcinoma of the head and neck. The Tarceva(TM) Phase III program in non-small cell lung cancer (NSCLC) is being conducted as a global alliance between OSI, Genentech and Roche and consists of three Phase III randomized studies; one trial assesses Tarceva(TM) as a single agent in a refractory setting and two trials are designed to assess Tarceva(TM) as first-line agent in combination trials with approved chemotherapy regimens. The design of the study in refractory NSCLC is investigating the potential survival benefit of single agent Tarceva(TM) at 150mg/day. This is the only single agent controlled Phase III study of an EGFR targeted agent designed to detect a survival advantage in refractory non-small cell lung cancer. The alliance's two front-line studies in non-small cell lung cancer are designed to assess the potential of survival benefit of Tarceva(TM) with standard chemotherapy. These trials contain noteworthy differences in study design versus those of the competitor trial results released today. The dose employed in the alliance's Phase III program of 150 mg/day is the apparent maximum tolerated dose (MTD) for this agent as determined in earlier Phase I studies. The choice of dose for the Phase III studies is based on the belief that this dosing strategy may be clinically important in the use of this agent. These studies are powered to demonstrate a 25% improvement in survival and are two-armed studies comparing Tarceva(TM)'s MTD with combination chemotherapy versus combination chemotherapy alone. All three NSCLC Phase III trials are progressing as planned. Accrual was recently completed for the first of the two front-line combination studies for Tarceva(TM) in non-small cell lung cancer (an approximately 1000 patient Genentech sponsored study combining Tarceva(TM) with carboplatin and Taxol®). Accrual to the other front-line combination study (an approximately 1000 patient Roche sponsored study combining Tarceva(TM) with gemcitabine and cisplatin) is currently on track. The single agent, refractory study (an approximate 330 patient OSI sponsored study in refractory NSCLC patients) is also progressing as planned.<< snip Can any biofreak say whether or not these trial design differences, and the differences in the drug itself are sufficient to give good odds of success despite Iressa's failure? Cheers, Tuck