Our latest European Society of Medical Oncology (ESMO) 2014 conference preview takes a look at some of the key immunotherapy sessions and presentations that look interesting in Madrid.
This last week saw the ASCO Breast Cancer Symposium in San Francisco, although very little caught my attention from a drug development point of view. Much of the attention seemed to be focused on surgery, genetic counselling and screening.
Yesterday’s biotech and pharmaceutical industry news was dominated by the FDA approval of PD-1 inhibitor pembrolizumab (Keytruda) from Merck for the treatment of advanced or unresectable melanoma in patients who no longer respond to other drugs (FDA announcement). Approval was widely expected after the compelling data presented at ASCO 2014 for both pembrolizumab, and another PD-1 checkpoint inhibitor, nivolumab (Opdivo), which was was approved in July in Japan for sale by Ono Pharmaceuticals, a partner of Bristol-Myers Squibb (BMS).
The big news yesterday evening was that Amgen’s phase III FOCUS trial in relapsed/refractory multiple myeloma failed to meet its primary endpoint of overall survival (HR=0.975).
This week Amgen announced that their second generation proteasome inhibitor, carfilzomib (Kyprolis), had met the primary endpoint of progression free survival (PFS) in the phase III ASPIRE trial. This study compared the triple combination of Kyprolis plus Revlimid and low dose dexamethasone (KRd) to the doublet of Revlimid plus low dose dexamethasone (Rd) in relapsed/refractory multiple myeloma. The overall survival (OS) is not yet mature and statistical significance was not been reached at the interim analysis. We will have to see how that data is looking in a few months time at the American Society of Hematology (ASH) meeting in December.
One of the things I most enjoy in cancer research is hearing wonderful patient stories from oncologists who are at the coal face of clinical trials. They get to deal with death and dying every day and like those in Pharma R&D, also live for the successes, the drugs that make it through pipeline despite great odds against them and make a meaningful impact on the daily lives of ordinary people.
Today’s post focuses on another question from a reader, who asked: “How will we decide which therapies to give patients with metastatic melanoma once the new immunotherapies are available?”
Acute Myeloid Leukemia (AML) is usually a disease of the elderly and an area of high unmet medical need, especially in those who unfortunately relapse post stem cell transplantation (SCT) or are considered ineligible for a transplant. In some ways, it has languished in the graveyard of R&D with very few new therapies approved by the FDA or EMA over the last decade. In fact, it has been quite the opposite with Pfizer’s gemtuzumab ozogamicin (Mylotarg), an anti-CD33 antibody drug conjugate (ADC) approved and subsequently withdrawn from the US marketplace following lack of confirmatory phase III data.
Previously, we discussed the role of new agents being developed for aggressive non-Hodgkins lymphoma (NHL) with Dr Nancy Valente of Genentech, particularly how their antibody drug conjugates (ADCs) could have a potential role to play in revolutionizing treatment for patients with an otherwise poor prognosis.
Over the last two years there has been a lot of focus on indolent lymphomas (iNHL) and chronic lymphocytic leukemia (CLL) with numerous new targeted therapies being tested in clinical trials including ibrutinib (Imbruvica), idelalisib, ABT–199 and IPI–145 to name a few.