Biotech Values

[DewDiligence]

Ipilimumamb Shows Modest Phase-2 Efficacy in NSCLC

[Metastatic melanoma, not NSCLC, is the lead indication for this immunotherapy from BMY (#msg-47415590). The eagerly awaited phase-3 Ipilimumab results in second-line melanoma will be presented at an ASCO plenary session on Jun 6.]

http://www.reuters.com/article/idCNN2021142420100520

›Thu May 20, 2010 6:28pm EDT
By Bill Berkrot

NEW YORK, May 20 (Reuters) - An experimental drug being developed by Bristol-Myers Squibb Co <BMY> when used with chemotherapy appeared to keep advanced lung cancer from progressing modestly longer than chemotherapy alone, according to a summary of data from a mid-stage study.

The biotechnology drug ipilimumab, which augments the body's immune response by inhibiting certain proteins, kept advanced non-small cell lung cancer from worsening about a month longer when given in addition to a chemotherapy regimen, data from an abstract of the study showed.

In the 203-patient study, subjects were given either ipilimumab in combination with paclitaxel and carboplatin, the Bristol drug followed by the chemotherapy drugs, or the chemotherapy drugs alone. [I.e. there were three arms: two arms with Ipi+chemo and a chemo-only control arm.]

Patients who received the drugs sequentially had median progression free survival of 5.68 months, compared with 5.52 months for those who received the drugs concurrently.

Both ipilimumab groups fared better than those who received only the chemotherapy. Median progression-free survival in that [chemo-only] group was 4.63 months, researchers said.

…Ipilimumab is considered one of the most important drugs in Bristol's development pipeline.

It is also being tested in metastatic melanoma, for which there are currently few treatment options. Highly anticipated late-stage data in melanoma has been kept under wraps and will be one of the highlight presentations at the June meeting.

In the lung cancer trial, the drug moderately added toxicity to the chemotherapy regimen and drug-related death rates were comparable across all treatment arms, researchers said.

The researchers conclude the results support further study of the Bristol drug [i.e. advancing to phase-3] in non-small cell lung cancer‹