HOUSTON--Adenoviral-p53 gene therapy with Introgen Therapeutics INGN 201 was well tolerated and showed evidence of clinical activity both alone and with cisplatin(Drug information on 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.