Phase III
The FDA decided last month to convene an advisory committee to discuss the companies’ proposed use of Abecma in earlier lines of treatment for multiple myeloma. Data presented Monday at the American Society of Hematology annual meeting provides a clue as to why.
The trial demonstrated that C3G glomerulopathy patients treated with the oral factor B inhibitor saw a significant reduction in protein in their urine. The results come days after iptacopan won the FDA’s green light for a rare blood disease.
Patients treated with the investigational sickle cell therapy saw an increase in hemoglobin levels and improved red blood cell parameters.
For the second time in as many days, Merck has reported a Phase III failure for its blockbuster PD-1 inhibitor Keytruda, this time as a first-line treatment with Eisai’s Lenvima for cancer in the uterus lining.
Results from a Phase III trial showed the combination improves progression-free survival compared to chemotherapy when used as a first-line treatment in metastatic colorectal cancer.
A combination of Merck’s experimental anti-TIGIT antibody vibostolimab and anti-PD-1 drug Keytruda failed to hit its endpoints in a mid-stage non-small cell lung cancer study.
In two late-stage trials, the experimental oral drug evobrutinib was unable to significantly reduce annualized relapse rates in MS patients compared with Sanofi’s Aubagio tablets.
A combination of Roche’s investigational treatment with Ibrance and fulvestrant met its primary endpoint of progression-free survival in the first-line setting in treating PIK3CA-mutated breast cancer.
Citing slow enrollment and low clinical rates, the late-stage “evidence trials” are being discontinued. AstraZeneca said there are no safety concerns and no impact on Lokelma’s current approved indication.
This week, the FDA could approve the first CRISPR-edited therapy in the U.S., while two other companies await decisions on topical drugs.
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