Amgen's Multiple Myeloma Drug Kyprolis Shows Positive Interim Results in Phase 3 Trial

By C. Rajan, contributing writer

Amgen and its subsidiary, Onyx Pharmaceuticals, have just announced encouraging interim results from their ASPIRE study for Kyprolis in patients with relapsed multiple myeloma. The ASPIRE Phase 3 clinical trial compared Kyprolis (Carfilzomib) to placebo in combination therapy with Celgene's Revlimid (lenalidomide) and dexamethasone therapy in patients with relapsed multiple myeloma. The results show that patients who received Kyprolis had significantly improved survival from 17.6 to 26.3 months without disease progression, as compared to patients who did not receive the drug.

Kyprolis was acquired by Amgen as a part of its takeover of Onyx last year in a $10.4bn deal. In July 2012, the U.S. FDA granted Kyprolis accelerated approval for treating multiple myeloma based on initial trial results. The complete results from the ASPIRE clinical trials will allow Amgen to seek full approval in order to expand the current indication in the U.S. and will also form the basis for global regulatory submissions in early 2015.

"In the treatment of patients with multiple myeloma, periods of remission become shorter following each treatment regimen, underscoring the need for new options. The results of the ASPIRE study demonstrate that Kyprolis can significantly extend the time patients live without their disease progressing," said Pablo J. Cagnoni, M.D., president, Onyx Pharmaceuticals.

Multiple myeloma is the second most common form of blood cancer, which develops in the bone marrow due to abnormal plasma cells. According to Amgen's press release, there are approximately 70,000 people in the U.S. living with multiple myeloma and about 24,000 new cases are diagnosed annually. Globally, about 230,000 people are living with multiple myeloma, with an additional 114,000 new cases being diagnosed annually.

According to Tony Hooper, Amgen's head of global commercial operations, the positive ASPIRE data will allow Kyprolis to move from third- to second-line use and will expand the potential patient population eligible to receive Kyprolis by two to three times. Kyprolis injection is marketed in the U.S. by Onyx Pharmaceuticals, and is already showing buoyant growth with second-quarter sales of $78m, over 15 percent higher than the first quarter.

In addition to the ASPIRE study, Amgen and Onyx also have several other Phase 3 clinical trials underway for Kyprolis:

• Phase 3 Study of Kyprolis in Combination with Melphalan and Prednisone Versus Bortezomib in Combination with Melphalan and Prednisone in Newly Diagnosed Multiple Myeloma – CLARION study
• Phase 3 Study of Kyprolis in Combination with Low-Dose Dexamethasone Versus Bortezomib in Combination with Low-Dose Dexamethasone in Relapsed Multiple Myeloma – ENDEAVOR study
• Phase 3 Study of Kyprolis Versus Best-Supportive Care in Relapsed and Refractory Multiple Myeloma – FOCUS study