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Avastin, Tarceva combination


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July 9, 2004 p39

Avastin, Tarceva combination yields initial promising results for


2004 JUL 9 -- Genentech, Inc., (DNA) and

OSI Pharmaceuticals (OSIP) announced results from phase I/II

clinical studies examining the combination of Avastin (bevacizumab)

and the investigational small molecule Tarceva (erlotinib HCl) in

the treatment of metastatic renal cell carcinoma (kidney cancer) and

relapsed non-small cell lung cancer (NSCLC).

These trials are important because patients received no chemotherapy

and instead were treated with a combination of two therapies

targeted at two distinct avenues of growth in cancer: angiogenesis

and EGFR signaling. The results were presented at the 40th Annual

Meeting of the American Society of Clinical Oncology (ASCO).

Avastin is a therapeutic antibody designed to inhibit angiogenesis,

the process by which new blood vessels develop, which is necessary

to support tumor growth and metastasis. Avastin is currently

approved in the United States for use in combination with

intravenous 5-Fluorouracil (5-FU)-based chemotherapy as a treatment

for first-line metastatic colorectal cancer.

Tarceva, an investigational therapy, is an oral, once-a-day, small

molecule designed to target the human epidermal growth factor

receptor 1 (HER1/EGFR) pathway, which is one of the factors critical

to cell growth in many cancers.

"As cancer patients lives longer, quality of life and avoiding toxic

side effects become more important," said Gwen Fyfe, MD, Genentech's

vice president, Clinical Hematology/Oncology.

"Evaluating the combination of Avastin and Tarceva in certain

cancers is representative of our strategy to inhibit tumor growth by

simultaneously targeting different cancer pathways. We are

encouraged by the response and progression-free survival data

observed in these studies of patients with advanced kidney and lung

cancers and believe these data support future evaluation of this

combination in multiple tumor types," Fyfe said.

In addition to the combination studies in recurrent NSCLC and

metastatic kidney cancer, preliminary data from studies evaluating

the combination of Avastin plus Tarceva in metastatic breast cancer

and recurrent and/or metastatic head and neck cancer will be

presented at this year's ASCO meeting.

This single-arm phase II study, presented by John Hainsworth, MD, of

the Sarah Cannon Cancer Center in Nashville, Tennessee, focused on

preliminary results from 62 patients with metastatic renal cell

carcinoma (kidney cancer) treated with a combination of Avastin and

the investigational drug Tarceva.

At the time of analysis, 62 patients had been enrolled in the study

and 58 were evaluable for response. The authors reported that at 8

weeks, 21% of patients (12/58) experienced an objective response

(defined as a 50% or greater decrease in the size of a tumor) to the

combined therapy and 66% (38/58) experienced a minor response or

disease stabilization. At 6 months, 67% of the evaluable patients

(39/58) had progression-free survival and after 1 year, 50% of

patients (29/58) had progression-free survival. Overall survival

after 6 months was 92% and after 1 year was 81%.

The Grade 3 or 4 adverse events observed in the study included

hypertension (8%, 5/58), diarrhea (10%, 6/58), rash (13%, 8/58),

nausea/vomiting (10%, 6/58), bleeding (5%, 3/58), pruritus (3%,

2/58), proteinuria (3%, 2/58), neuropathy (3%, 2/58) and edema (2%,


Alan Sandler, MD, of Vanderbilt-Ingram Cancer Center, reported on

results from a multicenter phase I/II study designed to evaluate the

combination of Avastin and Tarceva in the treatment of recurrent non-

small cell lung cancer (NSCLC) patients.

To date, 40 patients have been enrolled in the trial. At the time of

analysis, median survival was 12.6 months, median progression-free

survival was 7 months and the estimated 1-year survival was 54%.

Partial responses were observed in 20% of patients (8/40) and an

additional 65% of patients (26/40) achieved stable disease in the

study. The most frequent adverse events reported were mild-to-

moderate rash (93%, 37/40), diarrhea (78%, 31/40) and proteinuria

(18%, 7/40).

Traditionally patients with relapsed NSCLC are treated with

chemotherapy, which may be very poorly tolerated by some advanced

patients. If randomized, phase III trials of Avastin plus Tarceva

show clinical benefit, this combination could provide an important

treatment option that does not include chemotherapy.

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