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2016’s Worst Clinical Trial Failures
Several costly trial failures have made 2016 a depressing year for drug makers, according to Motley Fool analyst Cory Renauer. Bristol-Myers Squibb, Juno Therapeutics, Celldex Therapeutics, and Clovis Oncology all learned how hard it is to score a touchdown in the oncology game. Eli Lilly and Biogen, too, stubbed their toes with failed neurology drugs. Renauer reviewed seven initially promising medications that ultimately delivered nothing but heartbreak to their developers.
JCAR015 for Leukemia
Juno Therapeutics began 2016 on schedule to submit a new drug application to the FDA for JCAR015, an immune-cell therapy for patients with acute myeloid leukemia. In July, however, the FDA put the company’s pivotal trial on hold following the deaths of two patients. Juno blamed pretreatment chemotherapy as the culprit, and the agency allowed the study to continue with an alternative. In November, Juno halted the trial again after brain swelling led to two more deaths. This adverse effect was believed to be due to an excessive immune response. In other words, JACR015 worked too well.
Opdivo for Lung Cancer
Opdivo (pembrolizumab) stops programmed death ligand-1 (PD-L1), a protein found on the surface of tumor cells, from triggering a shut-off switch on immune cells. In August, Bristol-Myers Squibb announced that the treatment had failed to surpass standard chemotherapy in a study of newly diagnosed lung cancer patients expressing PD-L1 on 5% or more of their tumor cells. In October, Bristol added insult to injury when it revealed that not only had Opdivo failed to significantly increase progression-free survival, most of the patients receiving standard chemotherapy survived 40% longer without evidence of increased disease activity.
Opicinumab for Multiple Sclerosis
Opicinumab (Biogen) was designed to repair damaged myelin sheaths, which are vital to basic nerve-cell function. A phase 2 study in patients with a retinal disease suggested that the drug could increase the speed of signal transmissions between patients’ eyeballs and the backs of their brains, but there was little evidence that the treatment repaired damaged myelin.
In a subsequent trial involving multiple sclerosis patients, opicinumab failed to improve physical function, cognitive function, or disability.
Rintega for Brain Cancer
Rintega (Celldex Therapeutics), an oncolytic vaccine, demonstrated a long-term survival benefit compared with historical data in a phase 2 study. In a subsequent phase 3 trial, however, patients in the control group fared far better than those receiving the vaccine.
Rociletinib for Lung Cancer
In 2015, Clovis Oncology revised the percentage of patients experiencing tumor reductions after treatment with rociletinib, dropping the number from about 59% to between 28% and 34%, depending on the dosage. Unwisely, the company decided to submit a new drug application to the FDA. In April 2016, the agency refused to approve rociletinib without more data, as analysts expected.
RSV F Vaccine for Respiratory Virus
Phase 2 results suggested that RSV F (Novavax) was the first experimental vaccine to significantly reduce rates of respiratory syncytial virus infection compared with placebo, albeit by a slim margin. In a phase 3 study involving nearly 12,000 patients, however, a slightly higher percentage of older adults in the vaccine group became infected than in the placebo group.
Solanezumab for Alzheimer's Disease
To date, Eli Lilly may have spent more than any other drug maker in trying to conquer Alzheimer’s disease. The company’s solanezumab, a monoclonal antibody, failed to outperform placebo in three phase 3 trials after previous data hinted that there might be a chance the drug could slow the rate of cognitive decline in patients with early symptoms of dementia.
Source: The Motley Fool; December 21, 2016.