New data from the ASPIRE study of Amgen’s multiple myeloma therapy Kyprolis suggests the company’s ambition to extend the use of the drug into second-line therapy may be back on track.
Kyprolis (carfilzomib) is already approved as a third-line treatment for myeloma but the ASPIRE data shows that the drug can be safely added to standard chemotherapy, boosting its efficacy in patients who have relapsed after one course of treatment.
Amgen reported interim results from ASPIRE in August, but suffered a setback later that month when the results of the FOCUS trial – also in second-line treatments – failed to show any benefit on survival.
Updated results from ASPIRE reported at the American Society of Haematology (ASH) yesterday backed up the earlier findings on progression-free survival (PFS), showing that when added to standard therapy with lenalidomide and dexamethasone, Kyprolis provided almost a nine-month extension to more than 26 months.
The difference in overall response rates in the two treatment groups was also significant, at 87% in the Kyprolis group compared to 67% for lenalidomide/dexamethasone alone, a finding which Amgen said reflected a “superior depth of response.”
Secondary measures from the study – reported for the first time at ASH – reveal a trend towards improved overall survival with Kyprolis, which the company hopes may become a significant improvement as the data matures.
In addition, the median duration of response was improved from 21 months for standard therapy to almost 29 months, and patients on Kyprolis also reported significantly higher quality-of-life (QoL) scores. The new results are reported in the New England Journal of Medicine.
“By adding carfilzomib to the gold standard in multiple myeloma therapy, we are observing an unprecedented duration of remission without additional toxicity,” commented lead investigator Keith Stewart of Mayo Clinic Arizona in Scottsdale.
“We hope that the results of this trial will lead to approval of this treatment combination in patients with relapsed multiple myeloma worldwide,” he added.
Kyprolis was one of the drivers behind Amgen’s $10.4bn acquisition of Onyx last year and – while it has been growing steadily since its launch in 2012 with sales of $240m in the first nine months of the year – expansion of the label into the second-line and ultimately first-line is seen as imperative if it is to reach peak sales targets of $2bn or more per year. Amgen is also conducting a trial looking at first-line Kyprolis in myeloma called CLARION.
The results of the ASPIRE trial “will form the basis for regulatory submissions throughout the world beginning in the first half of 2015,” said the company, adding that it hopes the data will also allow for the conversion of accelerated approval to full approval and expand the current third-line indication.