OBI Pharma Inc (台灣浩鼎), which has been embroiled in an insider trading scandal over the past few months, on Saturday delivered a presentation on the phase II and III clinical trials of OBI-822, its new breast cancer drug, at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago.
Based on the clinical results presented at the event, the company said that although initial trials did not meet the primary efficacy end point of progression-free survival (PFS) in patients with late-stage metastatic breast cancer, a significant improvement was seen in half of the patients among a subset who demonstrated an immune response to the regimen.
PFS measured more favorably in 50 percent of patients in a subset of patients who produced an immune system response, the company said at a news conference held in Taipei yesterday.
Overall survival data remains inconclusive, the company said in a statement.
However, the company declined to address issues unrelated to the presentation at the ASCO meeting, leaving unanswered some shareholders’ questions regarding regulatory approval progress and commercialization.
“We are currently unable to release the data presented at the ASCO, due to a copyright agreement with the society,” OBI Pharma chairman Michael Chang (張念慈) said.
He said the company had presented its most vital findings during the 12-minute ASCO presentation and that further details would be disclosed at an appropriate time.
There is no embargo on information, Chang added.
The clinical trial results are encouraging and are to serve as a guide in shaping the design of upcoming clinical trials to allow improved identification of the patient population most likely to benefit from immunotherapy, said Hope Rugo, a director at the University of California, San Francisco’s Helen Diller Family Comprehensive Cancer Center, who served as an investigator in the study.
OBI Pharma shares on Saturday fell 1.82 percent to NT$594 in Taipei trading. The share price has swung wildly this year, as they began plunging late in February after the company first announced unfavorable clinical trial results, before rallying in the lead-up to the ASCO presentation.
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