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New data from combination therapy study presented at 56th annual conference of the American Society of Hematology
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Clinical benefit seen in all evaluable patients with advanced Multiple Myeloma
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Complete remissions observed in individual patients
-
Good response achieved in patients who did not respond adequately to other therapies
DREIEICH, Germany I December 9, 2014 I Biotest presented new clinical data derived from an ongoing combination study with BT-062 at the 56th annual meeting of the American Society of Hematology (ASH) in San Francisco. The Phase I/IIa study (Study 983) in multiple myeloma is investigating the safety and efficacy of BT-062 in combination with lenalidomide and dexamethasone in patients who have not been responding (any more) to previous treatments.
In the study, a total of 47 patients were treated with three different dosages up to maximum of 120 mg/m² BT-062, used in combination with lenalidomide and dexamethasone. Patients were treated until progression of the underlying disease or occurrence of unacceptable toxicities. 25 of the 47 patients enrolled are currently still on treatment, partly for up to 23 months.
Currently available efficacy data were evaluated from those 41 patients who had at least two efficacy assessments since the start of the treatment. All of these heavily pretreated patients showed clinical benefit from the therapy, achieving a stable disease or better. 78% of these patients had an objective response which ranges from a partial response to stringent complete response. Up to now 10% of the patients had a complete remission. Even in patients previously treated with both lenalidomide and bortezomib, an objective response rate of 68% was obtained.
The available data indicate that BT-062 is well tolerated in this combination regimen up to doses of 100 mg/m². .
Among the patients treated with the maximal tolerated dose (100 mg/m²), even 83% had an objective response.
Based on these encouraging data, it is planned to also evaluate safety and efficacy of BT-062 in combination with pomalidomide and dexamethasone in patients already exposed to lenalidomide and bortezomib.
Besides the multiple myeloma cells also many solid tumors express high levels of the CD 138 receptor. Biotest is conducting a monotherapy phase I/IIa study (Study 989) in triple negative metastatic breast cancer and metastatic urinary bladder cancer in Belgium and Germany.
SOURCE: Biotest
Post Views: 98
-
New data from combination therapy study presented at 56th annual conference of the American Society of Hematology
-
Clinical benefit seen in all evaluable patients with advanced Multiple Myeloma
-
Complete remissions observed in individual patients
-
Good response achieved in patients who did not respond adequately to other therapies
DREIEICH, Germany I December 9, 2014 I Biotest presented new clinical data derived from an ongoing combination study with BT-062 at the 56th annual meeting of the American Society of Hematology (ASH) in San Francisco. The Phase I/IIa study (Study 983) in multiple myeloma is investigating the safety and efficacy of BT-062 in combination with lenalidomide and dexamethasone in patients who have not been responding (any more) to previous treatments.
In the study, a total of 47 patients were treated with three different dosages up to maximum of 120 mg/m² BT-062, used in combination with lenalidomide and dexamethasone. Patients were treated until progression of the underlying disease or occurrence of unacceptable toxicities. 25 of the 47 patients enrolled are currently still on treatment, partly for up to 23 months.
Currently available efficacy data were evaluated from those 41 patients who had at least two efficacy assessments since the start of the treatment. All of these heavily pretreated patients showed clinical benefit from the therapy, achieving a stable disease or better. 78% of these patients had an objective response which ranges from a partial response to stringent complete response. Up to now 10% of the patients had a complete remission. Even in patients previously treated with both lenalidomide and bortezomib, an objective response rate of 68% was obtained.
The available data indicate that BT-062 is well tolerated in this combination regimen up to doses of 100 mg/m². .
Among the patients treated with the maximal tolerated dose (100 mg/m²), even 83% had an objective response.
Based on these encouraging data, it is planned to also evaluate safety and efficacy of BT-062 in combination with pomalidomide and dexamethasone in patients already exposed to lenalidomide and bortezomib.
Besides the multiple myeloma cells also many solid tumors express high levels of the CD 138 receptor. Biotest is conducting a monotherapy phase I/IIa study (Study 989) in triple negative metastatic breast cancer and metastatic urinary bladder cancer in Belgium and Germany.
SOURCE: Biotest
Post Views: 98
