Less than two weeks following the closing of Gilead’s acquisition of the company, Kite Pharma’s CAR-T immunotherapeutic, axicabtagene ciloleucel, has gained approval from the U.S. Food and Drug Administration as the first CAR-T therapy for an adult indication. The approval, which came more than a month ahead of the expected FDA decision date, is for...
Anticipation was high for the results of a Phase 3 trial of Axovant’s experimental drug, interpirdine. Sadly, the potential Alzheimer’s disease treatment failed to meet its co-primary endpoints. Patients with mild to moderate Alzheimer’s disease who were treated for 24 weeks with 35 mg interpirdine, along with the existing Alzheimer’s disease drug Aricept, failed to...
It is a not uncommon phenomenon for a new discovery to attract much enthusiasm and hype — as well as investment and new company formation — only to suffer popular disillusionment a few years later as public interest turns to the next hot area of science when clinical success remains elusive and far off. After...
The news from ESMO in September once again has highlighted the utility and need for biomarkers to help determine not only who will likely benefit from a particular immuno-oncology (IO) treatment, but also who may require a combination of such therapies right from the start. While higher levels of PD-L1 have generally correlated with...
We recently returned from the European Society for Medical Oncology (ESMO) 2017 meeting, which is the major meeting for oncology professionals in Europe, attracting over 24,000 participants from 131 countries. This fall meeting saw a lot of news, notably in the areas of lung cancer, breast cancer, and melanoma as well as immuno-oncology generally, including...
Head over to LinkedIn to read an article by our principal consultant Rachel Laing as part of our continuing commentary on Alzheimer’s Disease. https://www.linkedin.com/pulse/alzheimers-disease-diagnostic-dilemma-rachel-laing/
As cancer therapy moves towards the concept of “real-time” oncology — the ability to constantly monitor changes in a patient’s disease and adjust treatment accordingly — we see big data and high powered analytical approaches increasingly playing a key role. The aim of such efforts will be to find novel biomarkers and a new understanding...
Late August and early September was a period of big news — both positive and negative — on the CAR-T front. On the positive side, Novartis’ received the first FDA approval of a CAR-T therapy for Kymriah (tisagenlecleucel), for the treatment of children and young adults with B-cell precursor acute lymphoblastic leukemia that is refractory...
In July, we attended the Alzheimer’s Association International Conference in London. The big news at the meeting was on the diagnostics front. In the aftermath of the recent string of trial failures, diagnostic tools have become a critical area of focus, in the hopes that patient diagnosis and selection can be improved. Accurately diagnosing...
On July 27, AstraZeneca (AZ) disappointed their investors and many immuno-oncology watchers with the results of their MYSTIC trial combining two immunotherapies targeting PD-L1 (durvalumab/Imfinzi) and CTLA-4 (tremelimumab) in newly diagnosed Stage-IV lung cancer patients. The AZ combination therapy failed to show a benefit compared to chemotherapy in a primary endpoint of “Progression-free Survival (PFS).”...