ASCO Data Discussion - Final.

Original Source: FD (FAIR DISCLOSURE) WIRE

OPERATOR: Good afternoon. My name is Ian, and I'll be your conference operator today. At this time, I would like to welcome everyone to the Genentech analyst call from ASCO. All lines have been placed on mute to prevent any background noise. Your call will be done by Mrs. Morris today, and the call is scheduled to begin momentarily. Thank you.

MRS. MORRIS: Good evening, everyone, and thank you for joining us at our ASCO analyst [audio break]. Thank you for your patience. Sorry, we had a technical problem, as is often the case, so thank you for your patience and waiting for us. We are conducting a webcast, so there are people listening online. For those listening online, I have to say, unfortunately, because of the technical difficulties, you'll not be able to ask questions. We'll be taking questions from the live audience, however. If you have questions afterwards, please feel free either Diane [Shirk] or myself at investor relations to follow up [technical difficulty].

So, with that, I'd like to go ahead and get started. This call is being electronically recorded and copyrighted by Genentech, no reproductions, retransmissions or copies of this conference call can be made without the written permission of Genentech. We'll be making forward-looking statements, and actual results may vary materially [technical difficulty].

Today I am joined by Dr. Sue Hellmann, president of product development; Dr. Hal Barron, senior vice president and chief medical officer; Dr. David Schenkein, vice president of clinical oncology/hematology; Dr. Gwen Fyfe, vice president of clinical oncology; and Dr. Pam Klein, vice president of clinical oncology and hematology. And on the panel we also have joining us John [Orwin], vice president of sales and marketing for BioOncology.

We'll have each of our panelists have the opportunity to come up and make a few comments. We're going to save all the questions until all the people on the panel have had a chance to come up and make their comments, and then we'll open it up. So we'll begin with our opening comments from Dr. Susan Hellmann.

SUSAN HELLMANN: Thanks, Sue. I apologize that my voice is hoarse. This is day 4 of ASCO -- almost time to go home. Thanks, everyone, here for coming, and to those on the phone for joining us.

As you all know, it's an exciting time in oncology at Genentech. We are waiting to hear from FDA for six submissions that we've put in over the last several months -- Avastin for relapsed metastatic colorectal cancer; Herceptin is a treatment for adjuvant HER-2 positive breast cancer; Rituxan, a front-line treatment for indolent non-Hodgkins lymphoma; Avastin for first-line treatment of non-squamous, non-small cell lung cancer; and Avastin in the treatment of first-line metastatic breast cancer. And so it's been a time of a lot of filings for our team, and I'm proud of the work that everybody at Genentech has done. I think it's truly unprecedented to have this number of large submissions going in at once, and it's been a very good job.

The data that we presented this year at ASCO shed light on a lot of our earlier based programs like Omnitarg and Apo2L/Trail while also helping us understand how to maximize the benefits in areas where our products have shown to already be safe and effective, and we've learned a bit more about how to mitigate safety concerns from data such as the four-year update on cardiac dysfunction in the Herceptin adjuvant trial and the NSABPP-31, and finally we've learned more about combination therapies through the outcome of the Phase II chemotherapy plus or minus Avastin versus Avastin/Terceva in second lineup and also lung cancer earlier this evening.

David, Gwen, and Pam are going to discuss each of these trials in more detail, and I also want to thank all of our collaborators who work with us on these molecules for all their work on the studies as well as the patients and investigators who participated in the study.

Before we turn over the microphone for some comments on the studies, I wanted Hal to come up and tell you a little bit about our newest member of our BioOncology team. Hal?

HAL BARRON, SENIOR VP, CHIEF MEDICAL OFFICER, GENENTECH: Thanks, Sue. Thanks, everyone, for joining us. It's a real pleasure to be here at ASCO. I think probably my most enjoyable experience is generating and evaluating clinical data, but the second most favorite thing is being able to hire some of the best and brightest people to help us with our drug [technical difficulty]. In that light, I am pleased to introduce a new addition to the oncology senior management team, Dr. David Schenkein. He'll be the new head of clinical oncology and hematology.

In his position, David will be responsible for providing strategic medical and scientific leadership for the development of the BioOncology portfolio as well as oversight of the BioOncology clinical science and our medical science liaison function. David comes to Genentech from Millennium Pharmaceuticals, where he was most recently senior vice president of clinical research, and in part of that role he was the vice president and head of the clinical oncology group. Prior to his disposition with Millennium, David spent 18 years in academia clinical medicine at the New England Medical Center in Tufts University. So I just want to thank David for coming, and I'll turn it over to him to go over some of the data.

DAVID SCHENKEIN, VP OF CLINICAL ONCOLOGY/HEMATOLOGY, GENENTECH: It's an absolute privilege to join this fantastic team, and it's a pleasure to be here tonight to talk to you about two of the studies, and then Gwen and Pam will follow up with additional studies as well.

The first study that I'm going to just mention briefly, which was just presented a short time ago and then discussed at around 5:00 is the three-arm randomized Phase II trial in relapsed non-small cell lung cancer that looked at either chemotherapy alone, physician choice dose of Paxil or Pematrexid and placebo versus chemotherapy and Avastin. Those two arms were double-blind, placebo-controlled. And then arm three, which was …