ASCO confab highlights immunotherapies, 'breakthrough' drugs and small victories
CHICAGO--The showdown between Bristol-Myers Squibb ($BMY) and Merck ($MRK) over a new PD-1 approach to spurring an immune response to cancer didn't disappoint. Our FierceBiotech coverage over the weekend highlighted some solid data on nivolumab from Bristol-Myers as well as Merck's lambrolizumab. Both emerged as premier late-stage oncology efforts, with teams racing to see which will be the first to score a regulatory approval.
After a disappointing start, immunotherapies have become the hot new thing in cancer drug development, so you can expect to hear plenty more about that in the years to come. But there was a lot more to cover at ASCO.
The "breakthrough" drug designation from the FDA earned a lot of discussion over the past two days, with regulatory officials on hand to publicly vow that they will work closely with investigators on accelerating chosen programs. But there's little tangible evidence of just how this will pay off for drug companies. There was another round of small, incremental steps forward in drug development, with investigators seeing new treatment strategies deliver added--though rarely spectacular--progression-free or overall survival benefits for patients. And developers went deeper down the path of dissecting each type of cancer into smaller and smaller patient groups as they get better at following disease pathways and genetic triggers.
Here's a handy guide to our weekend coverage.
FDA oncology chief Pazdur vows to accelerate 'breakthrough' drug R&D
The FDA's oncology chief, Richard Pazdur, used his turn in front of the press mob at ASCO to make some very public vows about his commitment to the newly launched breakthrough-drug program, that intriguing new classification for certain stellar therapeutic programs that will be extended VIP status at the agency.
Merck's 'breakthrough' PD-1 cancer drug in showdown with Bristol-Myers combo
Merck's team arrived at ASCO with some solid positive data backing their melanoma program for lambrolizumab (MK-3475). The pharma giant is readying a pair of late-stage clinical trials for melanoma and non-small cell lung cancer as they set their sights on completing a speedy set of applications for regulators.
Bristol-Myers' immunotherapy drug nivolumab takes center stage at ASCO
Bristol-Myers Squibb arrived at ASCO with one of the most closely watched experimental immunotherapy drugs in the pipeline. And racing against some major league rivals, the biopharma company will leave with its frontrunner reputation for nivolumab intact.
AstraZeneca's selumetinib looks promising for rare cases of eye melanoma
As investigators narrow their search for effective remedies for more narrowly defined patient populations, clinical trials in oncology have sometimes begun to look more like the investigative work you find in the rare-disease arena. And nowhere was that more evident than in an ASCO presentation on the efficacy of AstraZeneca's ($AZN) selumetinib for rare cases of advanced melanoma in the eye.
Amgen trumpets T-Vec oncolytic virus results from PhIII melanoma study
Interim results from Amgen's ($AMGN) Phase III trial demonstrated the ability of talimogene laherparepvec, the oncolytic virus known as T-Vec, to shrink tumors while delivering some early signs of improved survival rates for melanoma patients.
Bayer's Nexavar hits the brakes on thyroid cancer progression
Bayer and Onyx ($ONXX) appear poised to expand sales of Nexavar (sorafenib). Investigators told the crowd at ASCO Sunday morning that their therapy almost doubled progression-free survival of treatment-resistant thyroid cancer patients, from a median 5.8 months in the control arm to 10.8 months in the treatment group.
Combo immunotherapies reduce risk of death for melanoma patients
Now that we know that a single immunotherapy can slow cancer, it stands to reason that two can do better. And that's what investigators say happened when they combined Sanofi's ($SNY) white blood cell booster GM-CSF with Bristol-Myers Squibb's Yervoy.
Avastin improves outcomes for cervical cancer but flunks first-line brain cancer test
Roche ($RHHBY) took two steps forward and one step back on the Avastin front today, as investigators laid out a clear advantage in adding the therapy to chemo for cervical cancer while finding no survival advantage when adding it to first-line treatment of an aggressive form of brain cancer.
Top 10 experimental cancer drugs - 2013
In our third annual report on 10 exciting cancer drugs, there are plenty of R&D programs zipping through trials with the blessing of the FDA, which has awarded "breakthrough" status for expedited development to treatments in oncology more than any other field.