This are not ground breaking results for NSCLC, and probably will not setisfy FDA apetite.
<<Tumor response duration ranged from 3 to 7+ months, and an additional 31% and 27% of patients had stable disease in the 250 and 500 mg/day ZD1839 arms, respectively. Symptom response rates were 43% for 250 mg/day and 35% for 500 mg/day, and the duration of response ranged from 1 to 7.4+ months. Approximately 60% of patients who experienced a reduction in disease symptoms did so by the second week of treatment. Median survival for the 250 and 500 mg/day ZD1839 groups was 6.5 and 5.9 months, respectively.>>
While I do not like TSC approach, his comments are valid in regards the PIII study, and I think that FDA will ask for it.
thestreet.com
Miljenko
Saturday May 18, 12:30 pm Eastern Time
Press Release
SOURCE: AstraZeneca
Pivotal Phase II Results for ZD1839 (IRESSA(R)) Reported in Advanced Non-Small Cell Lung Cancer
Data Presented at the American Society of Clinical Oncology (ASCO) 38th Annual Meeting
ORLANDO, Fla., May 18 /PRNewswire-FirstCall/ -- Final, Phase II results from the pivotal ZD1839 (IRESSA®) IDEAL 2 study were discussed today in an ASCO-sponsored news briefing, reporting ZD1839 treatment data in patients with previously treated advanced non-small cell lung cancer (NSCLC). Results from over 100 symptomatic patients treated with ZD1839 show reduction in tumor size in 12 percent of patients at a dose of 250 mg daily. Forty-three percent of patients experienced a reduction in lung cancer disease symptoms and, in these patients, many showed changes by the second week of treatment. The new IDEAL 2 data presented are consistent with the IDEAL 1 interim data first presented in November 2001.
Lead investigator of the IDEAL 2 study Mark Kris, M.D., Chief of the Thoracic Oncology Service at Memorial Sloan-Kettering Cancer Center, New York, N.Y., said, "The tumor response rates and rapid symptom changes we are seeing with ZD 1839 in this advanced disease population are important, especially when you consider that numerous other approaches have already failed in these patients."
IDEAL 2, a randomized, double-blind, parallel-arm study, was designed to evaluate tumor response, disease-related symptom response and the safety profile of ZD1839 monotherapy. 216 patients were randomized to receive oral ZD1839 at either 250mg per day or 500mg per day. All patients in the IDEAL 2 study had locally advanced or metastatic NSCLC, and all had received at least two prior chemotherapy regimens, including platinum-based therapy and docetaxel. One in four patients enrolled in IDEAL 2 had already been treated with four or more chemotherapy treatments. The study results indicate comparable responses and disease stabilization rates for both ZD1839 treatment arms.
Of the 216 patients treated, 102 received 250 mg/day and 114 received 500 mg/day of ZD1839; and 41% had failed 2 previous chemotherapy regimens, 33% had failed 3, and 25% had failed more than 4. Tumor response rates for the 250 and 500 mg/day ZD1839 groups were 11.8% (95% CI 6.2%-19.7%) and 8.8% (95% CI 4.3%- 15.5%), respectively.
Tumor response duration ranged from 3 to 7+ months, and an additional 31% and 27% of patients had stable disease in the 250 and 500 mg/day ZD1839 arms, respectively. Symptom response rates were 43% for 250 mg/day and 35% for 500 mg/day, and the duration of response ranged from 1 to 7.4+ months. Approximately 60% of patients who experienced a reduction in disease symptoms did so by the second week of treatment. Median survival for the 250 and 500 mg/day ZD1839 groups was 6.5 and 5.9 months, respectively.
The most commonly reported adverse events included reversible grade 1/2 diarrhea (48% for 250 mg/day and 67% at 500mg/day) and acne-like skin rash (43% at 250mg/day and 54% at 500mg/day). For patients receiving 250mg/day, grade 3/4 rash occurred in 1% of patients. For patients receiving 500mg/day, grade 3/4 diarrhea occurred in 1% of patients and grade 3/4 rash in 6% of patients. Withdrawals due to any drug related adverse event occurred in 1% of 250mg/day patients and 5% of 500mg/day patients.
The final results from the IDEAL 1 study will be presented at ASCO on Sunday May 19th, 2002, and are expected to concur with the previously reported interim results. Quality of life data from the IDEAL 2 study will also be presented, in addition to data evaluating ZD1839 in a broad range of solid common tumor types. Specifically, Phase II data on head and neck cancer will be presented on Tuesday May 21, 2002.
Other ongoing studies with ZD1839 include Phase III studies in NSCLC (INTACT 1 and 2), Phase II Head and Neck studies, hormone refractory prostate cancer (HRPC), breast and colorectal cancers, as well as early investigative studies in other tumor types. Studies of ZD1839 in earlier stages of NSCLC will be underway later in 2002.
ZD1839 is currently under regulatory review with the US Food and Drug Administration (FDA) and the Japanese Ministry of Health, Labor and Welfare (MHLW) for the treatment of advanced non-small cell lung cancer following the submission of clinical packages with data from IDEAL 1 and IDEAL 2 in December 2001 and January 2002, respectively. ZD1839 represents a new class of anti- cancer drugs known as selective epidermal growth factor receptor (EGFR) inhibitors. ZD1839 targets and blocks, within the cell, signaling pathways that are implicated in the growth and survival of cancer cells. These pathways appear to play a major role in the growth of many solid tumors. This targeted mode of action is different from cytotoxic chemotherapies and ZD1839 is administered as a once daily, oral tablet. |
