HOUSTON--Adenoviral-p53 gene therapy with Introgen
Therapeutics INGN 201 was well tolerated and showed evidence of
clinical activity both alone and with cisplatin (Platinol) in
patients with advanced non-small-cell lung cancer (NSCLC) who had
failed conventional therapy. Stephen Swisher, MD, of the M. D.
Anderson Cancer Center, presented the completed phase I/II trial
results at an ASCO poster session.
The trial, conducted at M. D. Anderson and Physician Reliance
Network, included 52 patients who received INGN 201 as a monthly
injection directly into a single primary or metastatic tumor.
Twenty-four patients also received IV cisplatin, 80 mg/m², 3
days prior to the INGN 201 injection. Each patient received up to 6
courses of treatment, and median follow-up was 9.9 months.
In patients receiving INGN 201 alone, 26 of 28 were evaluable. Two
patients had a partial response, and 16 had disease stabilization. Of
the 23 evaluable patients who received INGN 201 and cisplatin, three
(all previously treated with cisplatin) had a partial regression, and
17 had disease stabilization (10 previously treated with cisplatin).
Progression-free survival was increased at higher doses of INGN 201,
and was 2.4 months in patients given INGN 201 alone and 6.2 months
with the combination.
A phase II trial of INGN 201 plus radiotherapy is now underway at M.
D. Anderson in patients with previously untreated, nonresectable NSCLC.