Some key experimental drugs in late-stage testing by biopharmaceutical company Bristol-Myers Squibb Co.:
_ipilimumuab, for melanoma, the most dangerous type of skin cancer. Data from a late-stage study could be presented at a major cancer meeting in June; the company will soon seek regulatory approval for use in patients previously treated for the cancer. The company also will start a late-stage study of the drug for non-small cell lung cancer.
_apixiban, for preventing life-threatening blood clots. Bristol-Myers will seek approval in Europe by June and may see U.S. approval by year-end. It's also testing the drug for preventing strokes.
_belatacept, for preventing rejection of a newly transplanted kidney. A panel of Food and Drug Administration advisers voted 13 to 5 on Monday to recommend approval, and the agency could rule by May 1. Approval also is pending in Europe.
_dapagliflozin, to control blood sugar and reduce weight and blood pressure in diabetics. The company may file for U.S. and European approval by year-end.
_brivanib, for liver cancer. It's in late-stage testing.
_necitumumab, for non-small cell lung cancer. In late testing; being developed jointly with Eli Lilly & Co.
_XL-184, for brain tumors and other cancers. It's also in late-stage testing.
These are very impressive pictures. Any sense for the % of patients who respond to therapy? Also can anyone please review the mechanism of action and possibly compare to alternative new therapies e.g. telomerase inhibitors, hedgehog etc?? TIA bp
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.]
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‹
In the second-line setting, BMY has an Ipilimumab BLA pending based on the ‘020’ study with a PDUDA date of 3/26/11. An advisory panel for the second-line BLA was originally scheduled and was rescinded for unexplained reasons. An MAA is the EU is currently under review.
Those pictures are pretty damn incredible of what IPI is capable of doing in this type of met skin cancer.
GDC-0449 (Hedgehog) just hit its primary endpoints (CRIS, RHHBY). Roche also has Plexxikon's skin cancer drug (BRAF). Lots of activity in this area....
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