Amgen has stepped up its assault on the multiple myeloma market with new data showing that its Kyprolis helps patients live longer than Takeda’s rival drug Velcade.
The latest results from the ENDEAVOR trial of the two proteasome inhibitors shows that relapsed myeloma patients treated with Kyprolis (carfilzomib) lived more than seven months longer than those on Velcade (bortezomib), adding to earlier results showing an advantage for Amgen’s drug on progression-free survival (PFS).
The study is the first and only head-to-head trial of proteasome inhibitors to demonstrate a statistically significant improvement in overall survival, according to Amgen. Patients in the study had seen their disease progress after receiving between one and three prior treatment regimens.
It’s a boost to the company’s ambitions for Kyprolis, which took a hit last year when the drug failed to do better than Velcade as a first-line multiple myeloma treatment in the CLARION trial. Amgen said it will try to get the new results added to Kyprolis’ label, which could give it an edge in the second-line treatment setting.
Study investigator Meletios Dimopoulos of the National and Kapodistrian University of Athens in Greece said that for an incurable disease like multiple myeloma “a major treatment goal for oncologists and haematologists is to help patients live as long as possible.”
“Based on these data, we now know that Kyprolis not only significantly extended PFS compared to Velcade, but also overall survival, making it a clinically meaningful advance in the treatment of relapsed or refractory multiple myeloma.”
Amgen has insisted it remains committed to developing Kyprolis for front-line treatment of multiple myeloma despite the setback in the CLARION trial. It is currently designing a new phase III study that will pit Kyprolis against Velcade in newly-diagnosed, transplant-eligible multiple myeloma patients.
Amgen booked $692m from sales of Kyprolis in 2016, up by a third, but the drug is still lagging behind Velcade’s estimated $1.1bn in revenues last year. Multiple myeloma is becoming increasingly competitive, however, thanks to new launches such as Bristol-Myers Squibb’s Empliciti (elotuzumab), Novartis’ Farydak (panobinostat) and Johnson & Johnson’s Darzalex (daratumumab).
The proteasome inhibitor category has also experienced a shake-up with the launch of Takeda’s Ninlaro (ixazomib), the first orally-active drug in the class.
Multiple myeloma is incurable and characterised by a recurring pattern of remission and relapse. There are around 95,000 people living with or in remission from the cancer in the US.