Ipilimumab (Yervoy) failed to improve overall survival when combined with radiation in patients with advanced prostate cancer, researchers said. Also this week: Sanofi pulls lixisenatide application.
Yervoy Study Misses Primary Endpoint
Patients with prostate cancer and bone metastases after docetaxel treatment did not show significantly longer overall survival (OS) with ipilimumab (Yervoy) when used with single-dose radiotherapy, researchers reported.
In an abstract slated for presentation at the upcoming , released last week, a group led by of Nijmegen Medical Center in the Netherlands said that median OS was 11.2 months with ipilimumab versus 10 months with placebo in the 799-patient randomized trial (hazard ratio 0.85, 95% CI 0.72-1.00).
Because of the narrow miss for statistical significance, the researchers concluded that the trial "supports activity" of ipilimumab in advanced castration-resistant prostate cancer "by showing a numerical improvement" in OS. Progression-free survival (PFS) was significantly improved with the active drug (HR 0.70, 95% CI 0.61-0.82).
Gerritsen and colleagues noted that another trial is currently evaluating the drug in chemotherapy-naive patients with castration-resistant prostate cancer. Ipilimumab is currently approved for metastatic or unresectable melanoma.
Sanofi Pulls Lixisenatide Application
The French drug firm , citing concerns about "integrity" of data from an ongoing cardiovascular outcomes study.
In a statement posted on its website, Sanofi said the decision "follows discussions with the [FDA] regarding its proposed process for the review of interim data. Sanofi believes that potential public disclosure of early interim data, even with safeguards, could potentially compromise the integrity of the ongoing ELIXA study."
That study is being conducted to meet FDA requirements for dedicated cardiovascular safety trials for all new diabetes drugs. Sanofi said ELIXA is now fully enrolled with full results available at the end of 2014.
"The company plans to resubmit the NDA in 2015" after the study is completed, it said. It emphasized that no safety issues or other deficiencies in the application had been identified.
AAOS Joins "Choosing Wisely" Campaign
The has weighed in with a list of five common orthopedic treatments and tests that are often performed unnecessarily:
- Routine post-operative deep vein thrombosis ultrasonography screening in patients who undergo elective hip or knee arthroplasty
- Needle lavage in patients with symptomatic osteoarthritis (OA) of the knee for long-term relief
- Glucosamine and chondroitin to treat symptomatic OA of the knee
- Lateral wedge insoles for patients with symptomatic medial compartment OA of the knee
- Post-operative splinting of the wrist after carpal tunnel release for long-term relief
It's part of the campaign targeting healthcare interventions that raise costs with little or no benefit to patients. Some 30 medical societies have joined so far and about as many more are expected to release their own lists in the next year.
NIH Supports Rare-Disease Drugs
The NIH announced that it was , including one based on stem cell therapies and two to be conducted in collaboration with private pharmaceutical firms.
One, in partnership with researchers at Eli Lilly & Co., involves a long-acting parathyroid hormone analogue for treating hypoparathyroidism. The stem cell therapy -- specifically, retinal progenitor cells -- is for treatment of retinitis pigmentosa.
Retinitis pigmentosa is also the target of another program involving in Cambridge, Mass., which is developing a small-molecule "chaperone" -- a compound that helps an intracellular protein to fold into a desired 3-D conformation.
Finally, NIH is helping researchers at Beth Israel Deaconess Medical Center in Boston to develop rapamycin (Rapamune) to treat hypertrophic cardiomyopathy in , a genetic disorder marked by multiple congenital abnormalities in facial features and the skin as well as the heart.
Rapid Drug-Resistance Test for Malaria Reported
An international team of researchers that they had developed a 3-hour test for determining whether malaria parasites will resist artemisinin, the current standard of care for malaria treatment.
The technology offers a way to identify patients unlikely to clear parasites rapidly with artemisinin-based regimens prior to starting them on therapy, which is currently impossible.
The test is based on so-called ring-stage survival assays that determine how quickly parasites succumb to blasts of dihydroartemisinin, the drug's active metabolite. Within 3 hours, it was possible to distinguish parasites known to be resistant to the drug from susceptible isolates.
However, the 3 hours represented only the bench-top assay time, not sample preparation or other aspects of real-world testing protocols. The report also did not address the technology's costs, an important point for a disease that mostly affects resource-poor nations.
FDA: Arzerra a 'Breakthrough Therapy' for Newly Diagnosed CLL
Ofatumumab (Arzerra) has received extra-fast-track status from the FDA as a potential therapy for newly diagnosed chronic lymphocytic leukemia (CLL), its manufacturer said.
GlaxoSmithKline (GSK) said the drug in this indication had been , qualifying for expedited review and extra assistance from agency staff in preparing a marketing application. The designation came after the agency reviewed data from a that showed median PFS of 22.4 months with the drug combined with chlorambucil, compared with 13.1 months for chlorambucil alone (P<0.001).
Results of that trial are to be presented at the American Society of Hematology's annual meeting in December, GSK said.
Ofatumumab, an anti-CD20 monoclonal antibody that depletes B cells, is currently approved for treatment-refractory CLL.