Adenoviral-p53 Gene Therapy Promising in NSCLC

 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.