Data from Amgen that could ease some safety concerns about Kyprolis

Amgen ($AMGN) is still working to reassure investors that the $10.4 billion price tag it paid for Onyx in October 2013 was justified. To that end, it has more than 50 ASH abstracts, including the ASPIRE pivotal data for Kyprolis in relapsed multiple myeloma and for blinatumomab to treat adult acute lymphoblastic leukemia (ALL) and relapsed/refractory diffuse large B-cell lymphoma (DLBCL). (Blinatumomab was from Micromet, which Amgen acquired for $1.2 billion in March 2012.)

The ASPIRE data show a significant improvement in progression-free survival, but only a nonsignificant trend in overall survival. Leerink's Howard Liang suggests that data from the abstract including 24-month OS rates, ORR, median DOR, and CR and stringent CR rates point toward "a meaningful benefit." He doesn't expect additional important data at ASH, but thinks the oral presentation could "drive awareness of the results among clinicians and could help to usher in this regimen as the new standard of care for second-line MM."

The Phase III ASPIRE trial evaluated Kyprolis in combination with Revlimid and low-dose dexamethasone versus Revlimid and low-dose dexamethasone alone to treat patients with relapsed multiple myeloma after treatment with one to three prior regimens.

In a discussion with a pair of physicians about the ASH abstracts, Leerink noted that one finds it comforting that Kyprolis didn't show increases in the rates of cardiopulmonary toxicity as compared to the label, but another noted it had increased relative to control. Both doctors suggested that the toxicities are manageable, with some patients requiring particular vigilance.

Amgen hasn't gotten far with the blockbuster expectations for Kyprolis thus far. During the third quarter, Kyprolis had only $94 million in sales, an increase of 21% over the prior quarter. That's almost half the revenue generated by Pomalyst last quarter, which Celgene launched in a similar timeframe and has a different mechanism of action that targets similar patient population.

For more:
Survival miss for Amgen's Kyprolis may hurt approval chances in Europe
Amgen builds case for bigger Kyprolis market with impressive second-line data
Amgen preps for swift FDA review as Kyprolis/Revlimid combo stymies myeloma

Data from Amgen that could ease some safety concerns about Kyprolis
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