Replies to post #180950 on Biotech Values

[DewDiligence]

AMGN’s Kyprolis fails badly in phase-3 FOCUS study:

http://finance.yahoo.com/news/amgen-announces-top-line-results-200100572.html

…the Phase 3 clinical trial FOCUS (CarFilzOmib for AdvanCed Refractory MUltiple Myeloma European Study) did not meet its primary endpoint of improving overall survival (OS) (HR=0.975, 95 percent CI, 0.760, 1.249). The 315-patient, open-label study evaluated single-agent Kyprolis…compared to an active control regimen of low-dose dexamethasone, or equivalent corticosteroids, plus optional cyclophosphamide in patients with relapsed and advanced refractory multiple myeloma.

…Treatment discontinuation due to adverse events and on-study deaths were comparable between the two arms. The rate of cardiac events observed in the Kyprolis arm was consistent with the current U.S. Kyprolis label. There was an increase in the incidence of renal adverse events of all grades observed in the Kyprolis arm compared to the active control arm and the label.

[jq1234]

AMGN ASPIRE Kyprolis in relapsed MM detailed results published at NEJM:

Progression-free survival was significantly improved with carfilzomib (median, 26.3 months, vs. 17.6 months in the control group; hazard ratio for progression or death, 0.69; 95% confidence interval [CI], 0.57 to 0.83; P=0.0001). The median overall sur- vival was not reached in either group at the interim analysis. The Kaplan–Meier 24-month overall survival rates were 73.3% and 65.0% in the carfilzomib and control groups, respectively (hazard ratio for death, 0.79; 95% CI, 0.63 to 0.99; P=0.04). The rates of overall response (partial response or better) were 87.1% and 66.7% in the carfilzomib and control groups, respectively (P<0.001; 31.8% and 9.3% of patients in the respective groups had a complete response or better; 14.1% and 4.3% had a strin- gent complete response). Adverse events of grade 3 or higher were reported in 83.7% and 80.7% of patients in the carfilzomib and control groups, respectively; 15.3% and 17.7% of patients discontinued treatment owing to adverse events. Patients in the carfilzomib group reported superior health-related quality of life.

http://www.nejm.org/doi/pdf/10.1056/NEJMoa1411321

[DewDiligence]

AMGN submits sNDA & MAA for Kyprolis in second-line MM:

http://finance.yahoo.com/news/amgen-submits-applications-us-europe-210200219.html

In the US, Kyprolis is currently approved for third-line MM under an AA submission based on only the response rate; the sNDA seeks to expand the label and to obtain full-fledged rather than conditional approval.

[DewDiligence]

Kyprolis bests Velcade in phase-3 trial in second-line MM:

http://finance.yahoo.com/news/phase-3-head-head-endeavor-000000286.html

Amgen…today announced the results from a planned interim analysis showing that the Phase 3 head-to-head clinical trial ENDEAVOR evaluating Kyprolis (carfilzomib) for Injection in combination with low-dose dexamethasone versus Velcade (bortezomib) and low-dose dexamethasone met the primary endpoint of progression-free survival (PFS). Patients with relapsed multiple myeloma treated with Kyprolis lived twice as long without their disease worsening, demonstrating statistically and clinically significant superiority over Velcade (median PFS 18.7 months versus 9.4 months, HR=0.53, 95 percent CI, 0.44 – 0.65).

The Kyprolis combination demonstrated superiority over the Velcade combination for secondary objectives of higher overall response rate and lower neuropathy events. Overall survival data are not yet mature and continue to be monitored.

Wow. When the upper bound of the 95% CI for the hazard ratio of the primary endpoint (PFS in this instance) is as low as 0.65, that’s a great outcome.

Detailed results will be presented at ASCO.