Over the weekend oncology investigators from all around the world gathered in Madrid at the European Society for Medical Oncology (ESMO) 2014 Congress to review the latest advances--and setbacks--in the fast-moving field of cancer drug research. As usual, the big companies dominated the discussions, as rival oncology groups touted new data as they tried to position competing therapies in the global scramble to develop new and better cancer drugs, now one of the hottest fields in R&D.
Here's what won headlines at ESMO:
Bristol-Myers Squibb provides first look at promising PhIII nivolumab data
Bristol-Myers Squibb ($BMY) offered up a premier batch of late-stage evidence of the potential of its anti-PD-1 checkpoint inhibitor nivolumab (Opdivo). At the interim analysis the drug was credited with a 32% objective response rate among patients with advanced melanoma while the chemo control group registered only an 11% response rate.
"These data are important as they mark the first presentation of results from a Phase III randomized study for the PD-1 immune checkpoint inhibitor class," said Jeffrey S. Weber, director of the Donald A. Adam Comprehensive Melanoma Research Center at Moffitt Cancer Center. "Additionally, the response rate and duration of response in patients treated with Opdivo are consistent with findings from the early Phase 1 trial in previously treated advanced melanoma."
The nivolumab arm in the study also experienced a significantly lower rate of serious adverse events compared to the control--9% to 31%. In addition, investigators reported that the median response rate had yet to be hit in the nivolumab arm as responses were continuing.
Merck's already won an approval to use its rival checkpoint inhibitor pembrolizumab for melanoma, winning that particular race to the regulators. Most analysts are watching to see whether Bristol-Myers Squibb can do better in the lung cancer field, which has huge potential.
Roche, GSK tout new BRAF/MEK PFS rates for rival combos
Roche ($RHHBY) offered up new data on its combination of Zelboraf and cobimetinib, a one-two punch against BRAF and MEK, showing a significant improvement in survival times compared to the control arm's response to Zelboraf alone. Roche investigators demonstrated that the combo produced a median progression-free survival rate of 9.9 months among advanced melanoma patients compared to 6.2 months for the solo therapy.
GSK's ($GSK) rival BRAF/MEK combo--the already approved Tafinlar and Mekinist--meanwhile was highlighted for somewhat similar results, with a PFS of 11.4 months for their combo against 7.3 months for Zelboraf, according to a report from Reuters. That gives GlaxoSmithKline, which is flipping its oncology portfolio to Novartis ($NVS), a slight edge as the combos appear to be racing to a head-to-head showdown.
Exelixis has a lot riding on its partnership with Roche on cobimetinib. After the recent failure of its crucial study of cabozantinib for prostate cancer, the biotech laid off most of its staff and now needs all the good news it can get. Release | Reuters story
Merck adds fresh data to demonstrate broad potential of pembrolizumab
Merck ($MRK) turned up in Madrid with an early snapshot of a positive response to its anti-PD-1 checkpoint inhibitor pembrolizumab for stomach cancer--now freshly approved for melanoma as Keytruda. In a small study investigators tacked a 31% response rate for the treatment as a monotherapy.
What makes it important? Merck has been busily branching out on pembrolizumab to include a broad range of cancers, and pembrolizumab's early data here helps underscore the broad potential of its immuno-oncology program. Merck has a big ambition to fulfill in this area as it resets the course of its big R&D division under Roger Perlmutter.
"MSD is advancing the development of pembrolizumab across different tumour types and lines of therapy," said Dr. Alise Reicin, vice president, oncology, Merck Research Laboratories. "We are encouraged by the signals of anti-tumour activity in advanced gastric cancer, and are eager to move ahead with the Phase 2 study to better understand the potential of pembrolizumab in advanced gastric cancer." Release
Clovis surges as AstraZeneca confirms 2015 filing for rival cancer drug
Boulder, CO-based Clovis Oncology ($CLVS) got a boost this morning from news that AstraZeneca's rival program for the lung cancer drug AZD9291 was on track to be filed with regulators in the second half of 2015. Some analysts had been looking for a quicker filing, in light of the looming showdown with Clovis's CO-1686. There's been plenty of debate over the relative merits of each drug, with AstraZeneca forecasting a blockbuster future for its therapy. AZD9291 has been featured as one of the stars in the pharma giant's pipeline and proof of its R&D division's comeback potential. Clovis, which saw its shares spike 8% on Monday morning, also reported some updated preliminary results from its Phase II study of rucaparib for ovarian cancer at ESMO. Story
Hey, wait! Don't forget AstraZeneca's checkpoint inhibitor
AstraZeneca ($AZN) has been doing everything it can to move up in the frenetic race to develop new checkpoint inhibitors, and it made its best effort with a preliminary snapshot of positive results for a combination of the anti-PD-L1 MEDI4736 and tremelimumab in lung cancer. Up to now 18 patients have been treated and 5--or 28%--had responded with signs of tumor shrinkage, according to a Reuters report from Madrid. "It looks very, very promising," Scott Antonia of the Moffitt Cancer Center in Florida told Ben Hirschler. It also looks like very, very early data. Story