Iniparib News Leaves Breast Cancer Patients in Limbo (Again)
Hi. It's Dr. Kathy Miller back with another Medscape video oncology blog. It's been a little more than a week since we got our most recent scientific information the way we usually get scientific information these days: by way of a press release; this time it's from our colleagues at BiPar Sciences, Inc., and sanofi-aventis letting us know that BSI-201, otherwise known as iniparib, did not improve overall survival in addition to gemcitabine and carboplatin compared with chemotherapy alone.
This was the first of the PARP [Poly(ADP-ribose) polymerase] inhibitors. Huge news, plenary session at ASCO [2010 annual meeting of the American Society of Clinical Oncology] for the randomized, phase 2 trial recently published in The New England Journal of Medicine, and a treatment that all of our patients with triple negative breast cancer have been clamoring for. In fact, the company took the somewhat unusual step of initiating an expanded access program before we even had the results of the landmark clinical trial at hand.
To be fair, we've not actually seen the data. We've seen a press release that said the drug "did not meet its primary endpoint," but in reality there are a lot of reasons that a study might not meet its primary endpoint. Lots of randomized, phase 3 studies don't replicate the encouraging results of a randomized, phase 2, and we're going to need to see the data to try to understand what went wrong, what it teaches us, and more importantly where we go from here. That's the crucial question. Where do we go from here with this compound? Where do we go from here with other PARP inhibitors or other compounds that may have similar mechanisms of action? That's where the waiting becomes particularly tough.
The press release contains no data. We've not been provided the data, and we may need to wait until the next major oncology meeting, probably the ASCO meeting in June, before we can see the details of that data. That's my problem with this, the disconnect between the fiduciary responsibility to release information that could be material to the company's bottom line as soon as it's available and our desire in the scientific community to have that information be complete and peer reviewed. In the meantime, we can't make decisions. We can't move forward. We don't know what to do with our existing patients and with our ongoing trials, and 6 months is simply too long to wait. This is my call for us to all work together to find a way to let companies meet their fiduciary responsibility -- they need to do that -- but we also need to see the data, and we need to see the data much more quickly than our current system ever seems to make possible. For now we wait, but hopefully we can find a way to meet all of those needs without them competing and conflicting.
Hi. It's Dr. Kathy Miller back with another Medscape video oncology blog. It's been a little more than a week since we got our most recent scientific information the way we usually get scientific information these days: by way of a press release; this time it's from our colleagues at BiPar Sciences, Inc., and sanofi-aventis letting us know that BSI-201, otherwise known as iniparib, did not improve overall survival in addition to gemcitabine and carboplatin compared with chemotherapy alone.
This was the first of the PARP [Poly(ADP-ribose) polymerase] inhibitors. Huge news, plenary session at ASCO [2010 annual meeting of the American Society of Clinical Oncology] for the randomized, phase 2 trial recently published in The New England Journal of Medicine, and a treatment that all of our patients with triple negative breast cancer have been clamoring for. In fact, the company took the somewhat unusual step of initiating an expanded access program before we even had the results of the landmark clinical trial at hand.
To be fair, we've not actually seen the data. We've seen a press release that said the drug "did not meet its primary endpoint," but in reality there are a lot of reasons that a study might not meet its primary endpoint. Lots of randomized, phase 3 studies don't replicate the encouraging results of a randomized, phase 2, and we're going to need to see the data to try to understand what went wrong, what it teaches us, and more importantly where we go from here. That's the crucial question. Where do we go from here with this compound? Where do we go from here with other PARP inhibitors or other compounds that may have similar mechanisms of action? That's where the waiting becomes particularly tough.
The press release contains no data. We've not been provided the data, and we may need to wait until the next major oncology meeting, probably the ASCO meeting in June, before we can see the details of that data. That's my problem with this, the disconnect between the fiduciary responsibility to release information that could be material to the company's bottom line as soon as it's available and our desire in the scientific community to have that information be complete and peer reviewed. In the meantime, we can't make decisions. We can't move forward. We don't know what to do with our existing patients and with our ongoing trials, and 6 months is simply too long to wait. This is my call for us to all work together to find a way to let companies meet their fiduciary responsibility -- they need to do that -- but we also need to see the data, and we need to see the data much more quickly than our current system ever seems to make possible. For now we wait, but hopefully we can find a way to meet all of those needs without them competing and conflicting.