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"Treatment options for second-line SCLC are limited and preliminary datafrom the US-based Phase 2 sensitive SCLC trial indicate that Amrubicin mayprovide a new option for SCLC patients who desperately need more treatmentchoices," said principal investigator Robert M. Jotte, MD, PhD, MedicalDirector of the Lung Cancer Clinic of the Rockies, Developmental Co-Chair USONLung Committee. "As we near completion of the Phase 2 trial, we hope thataccrual to the Phase 3 trial will be rapid and confirm the results of the USPhase 2 trial and similar trials in Japan."
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The trial presented today compares Amrubicin and topotecan in patientswith ED-SCLC that initially responded to first-line platinum-based therapy butwhose disease recurred or progressed at least 90 days after completion offirst-line treatment (sensitive SCLC). Study participants are randomized in a2:1 ratio to receive either IV Amrubicin (40mg/m2 daily for 3 days) ortopotecan (1.5 mg/m2 daily for 5 days), both starting on Day 1 of a 21-daycycle.
Response data from 42 patients have been analyzed, 28 treated withAmrubicin and 14 with topotecan. Eleven of 28 (39 percent) patients whoreceived one or more cycles of Amrubicin have demonstrated a response,including two complete responses (CR) and nine partial responses (PR). Eightof the responses are confirmed and three are pending follow-up scans. Two of14 (14 percent) patients who received one or more cycles of topotecan had aresponse (both PRs). One is confirmed and one is pending a follow-up scan.
Survival times are not yet mature, however, at this time preliminary dataalready show an observed difference of 2.4 months in overall survival, whichtranslates to a hazard ratio of 0.67, favoring Amrubicin.
The most common adverse events were hematological and were generally equalbetween the two arms. No classical anthracycline cardiotoxicity has beenobserved to date, supporting data from earlier Japanese studies that suggestAmrubicin may be devoid of this anthracycline-associated adverse event.
A second Amrubicin Phase 2 trial is also underway evaluating single-agentAmrubicin in patients with ED SCLC that are chemo-refractory or progressivewithin 90 days of completion of first-line platinum-based chemotherapy(refractory SCLC). Study participants receive Amrubicin (40 mg/m2 via 5-minuteinfusion daily for 3 days) on Day 1 of a21-day cycle.
Enrollment in both second-line Phase 2 studies of Amrubicin is expected tocomplete by the end of 2007.
Pharmion has an additional ongoing Phase 2 study of Amrubicin in firstline SCLC patients in association with the European Organization for theResearch and Treatment of Cancer (EORTC). This study evaluates Amrubicin assingle-agent or combination therapy with cisplatin versus cisplatin plusetoposide in previously untreated ED-SCLC patients. Preliminary data fromthis study are expected in the second half of 2008.
Pharmion recently initiated an international pivotal Phase 3 trial ofAmrubicin versus topotecan as second-line treatment of small cell lung cancer(sensitive or refractory and limited or extensive disease). The randomized,controlled, multi-center study will compare Amrubicin to topotecan, the onlyapproved chemotherapy f
