The results of a three-phase clinical trial on multiple myeloma, published by Amgen, showed that compared with the approved dosage of twice a week, the combination of high dose of Kyprolis (Carfilzomib) and dexamethasone
, once a week, has reached a better effect, and it improved PFS.
More than 118,000 people in the United States have multiple myeloma. There are about 30,280 new cases per year and 12,590 deaths. In July 2015, the FDA approved Kyprolis with Revlimid and dexamethasone for treatment of multiple myeloma patients who have received 1-3 treatments. Kyprolis has also been approved as a single drug for patients with recurrent or refractory multiple myeloma. The drug can be used for treatment after a patient has received one or more treatments.
In this clinical study named ARROW, the Kyprolis and dexamethasone were given to patients who had received two or three other treatments before, including bortezomib and IMiD. The primary endpoint of the test is the non-progress survival (PFS) which is starting from the random group to disease developed or death. The secondary endpoints include total mitigation (ORR), overall survival (OS), safety and tolerance.
The research indicated that for patients with recurrent and refractory multiple myeloma, a high dose of Kyprolis achieved 3.6 months longer in PFS than the weekly routine dose group. The median progression-free survival period for patients treated with a high dose of Kyprolis was 11.2 months, the median progression-free survival period was 7.6 months in patients treated with two conventional doses of Kyprolis combined with dexamethasone. Patients in the weekly treatment group received 70 mg of Kyprolis, while the weekly treatment group received 27 mg of Kyprolis each time.
The most frequently reported adverse effects (> 20%) were anaemia, diarrhea, fatigue, high blood pressure, insomnia and fever. Dr. Sean Harper, executive vice President of research and development of Amgen, said: "Kyprolis has been shown to be the most effective protease inhibitor in patients with multiple myeloma, we are encouraged by the efficacy and safety of the Kyprolis and dexamethasone in the ARROW test."
Wuxi: a summary of recent progress in the field of pantry | oncology (phase 42), 2017-10-30