With its lead drug ponatinib on track to a likely approval in the U.S. and Europe, Ariad Pharmaceuticals ($ARIA) moved center stage at ESMO 2012 over the weekend with an early-stage cancer drug that produced some impressive results among a small population of non-small cell lung cancer patients.
"The study provides compelling clinical evidence of the anti-tumor activity of AP26113 at multiple dose levels in patients with anaplastic lymphoma kinase positive (ALK+) NSCLC and initial clinical evidence of anti-tumor activity in patients with epidermal growth factor receptor mutant (EGFR-m) NSCLC," noted Ariad in a release.
Among the groups of patients enrolled in a dose-ranging Phase I/II study of AP26113 for ALK-positive cases, 8 of 11 saw their tumors shrink during the course of the study. Two of the patients not yet treated with Pfizer's ($PFE) Xalkori also responded to the drug. And of the 6 EGFR patients who no longer responded to Tarceva, one demonstrated a partial response with two stable and three seeing their cancer worsen.
"The initial findings from this ongoing study show that AP26113 has impressive anti-tumor activity in ALK+ NSCLC patients, who are either naïve or resistant to crizotinib," said Yale's Scott Gettinger in a prepared statement. "At the same time, it is encouraging to see a partial response in a patient with EGFR-mutant lung cancer and acquired resistance to erlotinib in the Phase 1 dose-escalation portion of the trial."
Ariad CEO Harvey Berger, who's been setting up commercial operations for ponatinib, tells Reuters that the company will now move '113 into a mid-stage program. "Our ultimate goal in development of '113 will be to apply it first to ALK, then EGFR in those patients who have become resistant or intolerant to available therapies."
- here's the press release
- here's the story from Reuters
ESMO ROUNDUP: Orion takes center stage with promising prostate cancer drug
VIENNA - Finland's Orion Pharma jumped into the limelight at ESMO over the weekend as well with its early-stage Phase I/II data on ODM-201, noting a prostate specific antigen response in 13 of the 15 patients in the trial. "It is really rare in my experience to see a drug so benefiting in such an early phase of development to most patients, and I'm excited that we can now pursue the assessment of ODM-201 in more patients with mCRPC, including hard to treat disease situations," says Karim Fizazi, head of the department of cancer medicine at Institut Gustave Roussy. Release