The survival benefit seen in Genentech/OSI's Tarceva non-small cell lung cancer monotherapy trial shows it is a "better product" than AstraZeneca's Iressa , Genentech maintained April 26.

"At this stage, from a commercial/promotional point of view, we have a different and better product," Genentech VP-BioOncology Ian Clark told investors.

"AstraZeneca has yet to demonstrate a survival benefit" with Iressa (gefitinib), "and they've yet to demonstrate that they can elevate the dose of Iressa safely in their patient population. So for now, we think we've made a very strong statement of differentiation for Tarceva," OSI CEO Colin Goddard, PhD, said.

One of AstraZeneca's postmarketing studies for Iressa is modeled on the Tarceva monotherapy study. The trial is due to be submitted in October 2005 (see ¹ Also see "Iressa Survival Study Is Ahead Of Schedule, AstraZeneca Says" - Pink Sheet, 3 May, 2004. ).

Tarceva (erlotinib) may have further advantages "from a kinetic, dynamic, crystalline structure, potency, or dose point of view," Genentech and OSI maintained.

The firms reported that the monotherapy trial (BR21) also met its secondary endpoints of time to symptomatic worsening, progression-free survival and response rate. Data from the trial are slated for presentation in June at a late-breaking session at the American Society of Clinical Oncology annual meeting.

The positive results follow an announcement last October of Tarceva's failure to show a survival benefit in two combination therapy studies (TALENT and TRIBUTE). OSI and Genentech revised their NDA filing timeframe for early 2004 to await the monotherapy data (² Also see "Genentech/OSI Tarceva NDA Filing Will Wait For Phase III Monotherapy Data" - Pink Sheet, 6 October, 2003., p. 38).

A rolling NDA started Jan. 21 with submission of non-clinical and chemistry, manufacturing & controls portions. The remaining data are expected to be submitted this summer. The firms are seeking an indication for treatment of incurable stage IIIB/IV NSCLC in patients who have failed standard therapy for advanced metastatic disease.

"With a later than anticipated unblinding this past weekend, it is reasonable to estimate completion of filing during the summer and - assuming a successful six-month priority review of our application by the FDA - launch of Tarceva in the U.S. should be anticipated during 1Q 2005," Goddard said.

"It is possible...that [the FDA] could move quickly, but it's not appropriate for us to model that and I think our guidance is appropriately set to 1Q 2005," Goddard told analysts who called the timeframe conservative.

European partner Roche "will complete their filing on approximately the same timeline, but with a longer review time anticipated within Europe, launch in Europe would be...more towards the back end of 2005."

Goddard indicated that pricing will depend on Tarceva labeling. OSI and FDA will "think that through over the coming months. We do think this [monotherapy] result represents a differentiated product and I'm sure that's going to be taken into consideration in our thinking as we plan for the future."

OSI and Genentech are discussing the specifics of their copromotion agreement. "Genentech clearly has the lead role in marketing and launching the product," but OSI will be adding some additional reps.

"We have approximately a 30-person sales force in play at the moment, and we would expect to see that increase not only around Tarceva but with a lot of the other things we have to do with this company going forward, to probably about double that over the next year or so."

Across the tripartite alliance of Genentech, OSI and Roche, Goddard said there are over 100 ongoing Tarceva studies. "Moving the drug into earlier stage disease in many forms is an attractive possibility for us."

Genentech pointed to Tarceva use in combination with its recently approved targeted oncologic Avastin (bevacizumab) as one of the most exciting prospects.

"We think actually combining Tarceva with other targeted agents may be preferable for activity with targeted agents. We'll be looking at that in the near future," VP-Clinical Hematology/Oncology Gwen Fyfe, MD, said. The positive survival outcome "now gives us an opportunity to develop Avastin and Tarceva in a variety of solid tumors."

Tarceva Survival Benefit Differentiates Oncologic From Iressa – Genentech

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