Here is an info update on the drug, Romidepsin, that one of our readers, Elizabeth, commented about earlier in the week:
Romidepsin is a late-stage oncology drug candidate being studied across a range of hematologic malignancies. Over 850 patients have received romidepsin in clinical trials. A registration trial in cutaneous T-cell lymphoma (CTCL) has recently been completed, successfully exceeding its primary endpoint based on overall response rate. A registration trial in a second indication, peripheral T-cell lymphoma (PTCL), is currently enrolling patients. Complete and durable responses were observed in a previous National Cancer Institute trial including both patients with CTCL and PTCL. Numerous other Phase 1 and Phase 2 trials are ongoing in additional indications in solid tumors and hemotologic malignancies, including multiple myeloma. These studies include single-agent romidepsin as well as romidepsin in combination with leading cytotoxic agents. The studies are being conducted by Gloucester Pharmaceuticals, the National Cancer Institute (NCI) through a Cooperative Research and Development Agreement (CRADA) with the Company or under investigator-held INDs. Romidepsin has been studied in clinical and preclinical studies under the names of romidepsin, depsipeptide and FK228.
Romidepsin in Multiple Myeloma
Romidepsin has shown activity in multiple preclinical models of multiple myeloma, both as a single agent and in combination with other agents. Synergism with Velcade® (bortezomib) has been demonstrated in preclinical models that are Velcade® sensitive as well as Velcade® resistant.
Multiple studies of romidepsin in multiple myeloma are currently underway or planned, including an ongoing investigator-sponsored Phase 1/2 study in combination with Velcade® and dexamethasone and a Gloucester-sponsored Phase 2 study (GPI-08-0006) in combination with Velcade® which is currently enrolling patients.
Multiple Myeloma Clinical Program Results
Interim data from the investigator-sponsored Phase 1/2 study were presented by Dr. Simon J. Harrison of the Peter MacCallum Cancer Centre in Melbourne, Australia at the 50th American Society of Hematology (ASH) Annual Meeting held in San Francisco, CA. In the study, patients with relapsed or refractory multiple myeloma who received romidepsin in combination with Velcade® and dexamethasone had an overall response rate of 85% (17/20). Four (20%) patients achieved a complete response (CR), two (10%) a very good partial response, six (30%) a partial response (PR) and five (25%) a minor response (MR). Five of six patients previously exposed to Velcade® responded in this study, including a negative immunofixation CR, one PR and three MRs. The median time to progression for all patients was seven months.
About the Phase 1/2 Romidepsin Multiple Myeloma Trial
The Phase 1/2 study is an open-label, single-center, single-arm, dose-escalating trial of romidepsin in combination with Velcade® and dexamethasone followed by maintenance romidepsin therapy until disease progression. In the Phase 1 portion of the study which enrolled 10 patients, the maximum tolerated dose was determined to be 10 mg/m2 of romidepsin, 1.3 mg/m2 of Velcade® and 20 mg of dexamethasone. To date, this ongoing study has enrolled 22 patients, with 20 patients currently evaluable for response. Patients receive romidepsin on days 1, 8 and 15, receive Velcade® on days 1, 4, 8 and 11 and receive dexamethasone on days 1, 2, 4, 5, 8, 9, 11 and 12.
The most common adverse events were sensory or motor neuropathy (41%), nausea (36%), fatigue (32%), constipation/diarrhea (32%), infection (32%) and cyclic thrombocytopenia (27%). The most common Grade 3/4 adverse events were sensory or motor neuropathy (18%), infection (14%) and cyclic thrombocytopenia (14%).This study continues to enroll patients and the Company anticipates that updated results will be presented at a future scientific meeting.
That information was taken directly from the Gloucester Pharmaceuticals Website.
Looks like another bullet in our battle against multiple myeloma. My concerns are two-fold: First, as I have written in the past, are drug companies spending too much time and money on drugs like Romidepsin that aren’t potential cures, only band-aids? And second, can our bodies (your and mine!) withstand the constant assault of drug after drug, poison after poison we all face everyday? More about this tomorrow.
Poison or no poison, feel good and keep smiling! Pat