Amgen Announces Detailed Results From Phase 3 ASPIRE Study Of Kyprolis

(RTTNews) - Amgen (AMGN) and its subsidiary Onyx Pharmaceuticals Inc., announced results of the Phase 3 ASPIRE (CArfilzomib, Lenalidomide, and DexamethaSone versus Lenalidomide and Dexamethasone for the treatment of PatIents with Relapsed Multiple MyEloma) trial, which evaluated Kyprolis (carfilzomib) for Injection plus Revlimid (lenalidomide) and dexamethasone or KRd compared with Revlimid and dexamethasone or Rd in patients with relapsed multiple myeloma.

Previously, the company had reported that the ASPIRE study met its primary endpoint by demonstrating that KRd significantly extended the time patients lived without their disease worsening, or progression-free survival or PFS, by 26.3 months compared to 17.6 months with Rd (HR=0.69; 95 percent CI: 0.57-0.83; p<0.0001), an 8.7 month improvement in PFS.

Secondary endpoints, which are being presented for the first time, included overall survival (OS), overall response rate or ORR, duration of response (DOR), health-related quality of life (HR-QoL) measures and safety. While the data for median OS are not yet mature based on the prespecified statistical boundary at the interim (p=0.005), the analysis showed a trend in favor of KRd compared with Rd (HR=0.79; 95 percent CI: 0.63-0.99; one-sided p=0.018, two-sided p=0.04). Patients will continue to be monitored for OS.

The ORR was 87.1 percent with KRd and 66.7 percent with Rd (one-sided p<0.0001, two-sided p<0.001). In the KRd and Rd groups, 14 percent versus 4.3 percent of patients achieved a stringent complete response, a measurement indicating superior depth of response. Median DOR was 28.6 months (KRd) and 21.2 months (Rd). KRd consistently improved Global HR-QoL compared with Rd over 18 cycles of treatment (one-sided p=0.0001, two-sided p<0.001).

Treatment discontinuation due to an adverse event (AE) occurred in 15.3 percent (KRd) versus 17.7 percent (Rd) of patients. In the KRd arm, 7.7 percent versus 8.5 percent (Rd) of patients died while still on study treatment or within 30 days of receiving the last dose of study treatment.

The company noted that results from the ASPIRE trial will form the basis for regulatory submissions throughout the world beginning in the first half of 2015. In the U.S., the data may support the conversion of accelerated approval to full approval and expand the current indication.

Multiple myeloma is the second most common hematologic cancer and results from an abnormality of plasma cells, usually in the bone marrow.