Gilead Sciences said an independent review of interim Phase 3 data found the immunotherapy, magrolimab, led to a higher risk of death. Though Gilead is discontinuing further development of the drug in blood cancers, a review is ongoing in solid tumors.
2seventy Bio reported that an acute myeloid leukemia patient treated with its experimental cell therapy has died, prompting research partner Seattle Children’s Research Institute to pause the Phase 1 study. The FDA has been notified and an investigation is underway.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Gilead Sciences is betting that a MacroGenics antibody drug for blood cancers can offer a safety edge over others that address the same target. It’s the second partnership between the two companies; an alliance that began in 2013 expired without Gilead licensing any molecules from the deal.
The lead cancer drug candidate of Foghorn Therapeutics is now under a partial clinical hold following a patient death. According to the biotech, the patient may have experienced a side effect that is a known complication of leukemia drugs.
The FDA placed the partial hold on the study last November following a patient death suspected to be linked to a known complication of leukemia therapies. Kura Oncology said it has reached agreement with the FDA on a mitigation strategy for that complication.
The FDA placed a partial clinical hold on a Kura Oncology leukemia drug following the death of one patient in the early-stage study. Kura executives said the death may be related to differentiation syndrome, a known complication of leukemia therapies.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
BMS received approval for Onureg in the continuation setting of acute myeloid leukemia. The drug uses the same pharmaceutical molecule as Vidaza, a drug given via IV or subcutaneously that is used upfront, but it is not intended as a substitute for it.
The company has raised $148 million so far and plans to raise the remaining $7 million by next month. Its lead candidate is entospletinib, a SYK inhibitor acquired as part of a deal with Gilead Sciences last month, under development for patients with biomarker-defined acute myeloid leukemia.
Experts expressed dismay at single-agent data from the Phase I study, which a spokesperson noted was still in dose expansion. However, the drug could have a future in combinations or in patients with minimal disease left over after prior treatment.
The company presented Phase Ib data for magrolimab, a CD47 inhibitor, in AML and MDS. An interviewed executive and an investigator expressed particular excitement about complete responses in a poor-prognosis patient subset, in addition to the general AML population.
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The companies said Venclexta extended overall survival in untreated acute myeloid leukemia patients when combined with Bristol-Myers Squibb's Vidaza. A prior Phase III confirmatory trial, combining the drug with low-dose cytarabine, failed.
The company announced the presentation of data at the ESMO meeting in Barcelona for Tibsovo, in patients with IDH1-mutant bile duct cancer. The drug is approved for treating IDH1-mutation positive acute myeloid leukemia.
The outcome was not surprising, in light of a negative vote by an FDA expert panel last month, but an investigator in the study criticized the agency's approach as being based on a poor understanding of acute myeloid leukemia.
A company spokesperson said the company was working to address the agency's concerns about the drug, quizartinib, for FLT3-mutated acute myeloid leukemia.
The hold had been placed in February following two deaths in the study, including one in a patient who experienced cytokine release syndrome. The company has amended the trial protocol to mandate monitoring and management of CRS.