July 4th, 2014
Gilead Sciences continues to invest in the drug originally known as CAL-101 and now known as idelalisib. Gilead acquired this drug along with the rest of Calistoga Pharmaceuticals back in 2011. Clinical trial data for both CLL and non-Hodgkin’s lymphoma look good, and the FDA is scheduled to complete a priority review of Gilead’s New Drug Application for CLL by early August and for NHL by early September.
There are 11 clinical trials currently open and recruiting new patients. Importantly (and congratulations to Gilead for doing the right thing!) there is an expanded access program for patients with relapsed, previously-treated CLL who are not eligible for other Gilead clinical trials. The expanded access protocol provides for idelalisib to be used in combination with rituximab.
Although for some patients, diarrhea is a serious side effect, for many people it is not severe and can be controlled with other medication. In general, this is a much milder drug than many options that people with cancer must choose from, and the efficacy results some patients have experienced is quite dramatic.
Of note is a mouse study recently published in the scientific journal “Nature.” It turns out that, in mice at least, this drug works rather well against solid tumors. Earlier in the drug’s development, the expectation was that it would be limited to use primarily against leukemias and lymphomas rather than solid tumors. It will be a while before human clinical trials test the usefulness of this new drug against solid tumors, but it’s certainly worth watching and keeping in mind as more data become available.
February 26th, 2013
Cal-101, now called GS-1101, is an oral drug (technically a PK13-delta inhibitor) developed by Calistoga Pharmaceuticals showing great promise for the treatment of certain non-Hodgkin’s lymphomas and chronic lymphocytic leukemias. Calistoga was taken over by Gilead Sciences which is now advancing the experimental drug through Phase 3 clinical trials.
We have heard very positive things about the performance of GS-1101. Unfortunately, Gilead did not respond to our request for additional non-confidential information, so we will do other research and post additional perspectives here as we are able. There are a number of clinical trials open for enrollment, and you can do a little research on your own at the NCI’s clinical trials site: http://www.cancer.gov/clinicaltrials/search/results?protocolsearchid=11431626
May 31st, 2011
The World Health Organization released an announcement today linking cell phone use to a possible increased risk for glioma, a malignant brain cancer. Possibly more significant is evidence that low level cell phone radiation may increase the risk of damage to brain tissue (in the same way that microwaves cook meat), resulting in impairment of some neurological functions.
The mobile phone industry is certain to reject WHO’s findings due to their overwhelming financial interest in having the link not be credible. There are sure to be claims and counter-claims in the coming years over the interpretation of the statistical data WHO used to reach their conclusions, and there will undoubtedly be political debates over the question of regulation of cell phones from a public health standpoint. The WHO press release can be found at this link: WHO cell phone cancer risk.
While the WHO study does not claim proof of a cause – effect relationship between cell phone use and glioma or other brain health issues, everyone deserves access to as much detailed information as possible to make an informed personal choice, even when the evidence is not yet definitive.
August 4th, 2010
Although living without disease progression is clearly a good thing, in the ongoing debate over the use of progression-free survival (PFS) as a formal endpoint in clinical trials, one frequent concern is how does PFS relate to overall survival (OS) or extension of life. As a follow-up to our earlier post, we thought you might be interested in seeing what some of the experts have to say. The following link will take you to a summary of a paper published in late 2009 in the Journal of the National Cancer Institute in which leading statisticians analyze the relationship between PFS and OS in the context of how long a person is likely to survive after disease progression, something that varies substantially among different cancer types and stages.
JNCI December 2009
Although there are many aspects to consider in the PFS versus OS debate, one of our concerns is that by discounting a significant increase in PFS when it is not acccompanied by a statistically significant increase in OS, we might be rushing to judgement and missing important clinical benefits for some patients provided by a treatment that does not work for every patient.
Clearly, better tools are needed to predict which patients will benefit and which will not benefit from any given treatment (and importantly, which will be harmed), but that is a topic for another post. . .