Immunomedics Inc. (IMMU, Financial) filed Annual Report for the period ended 2010-06-30.
Immunomedics Inc. has a market cap of $219 million; its shares were traded at around $2.91 with a P/E ratio of 5.9 and P/S ratio of 7.3.
For the 15 evaluable NHL patients reported at the conference, 53% had an objective response, and 27% had a complete response. In follicular lymphoma, 7 of 12 patients (58%) had objective responses, with 3 patients (25%) having complete responses. These findings were comparable to the Phase II results we had published using the intravenous formulation. Moreover, 7 of the 8 objective responders are currently continuing in remission, now up to 6 months after treatment. Thus, despite the small number of patients, it appears that the subcutaneous formulation of veltuzumab may be active against NHL.
In 37 evaluable patients, the disease control rate for all dose groups combined was 57%, including 6 patients (16%) with partial responses, or PR, by RECIST criteria (i.e., responses showing decreases in tumor size of more than 30% by CT and in the absence of new lesions), and 16 patients (41%) with stable disease, or SD. Most
promising efficacy was observed in the group of 16 patients that received 12 mCi/m2 of Y-90 weekly for 3 weeks, with a 69% disease control rate (19% PR and 50% SD). In addition, anecdotal reports indicated patients have good performance and decreased pain medication after treatment.
Results from a Phase I/II European study evaluating fractionated dosing of Y-90 epratuzumab tetraxetan (two or three weekly infusions of Y-90 epratuzumab tetraxetan) in 64 adult patients with relapsed/refractory NHL, including 17 patients who underwent prior autologous stem-cell transplantation, or ASCT, were recently reported in the Journal of Clinical Oncology. The overall response rate, or OR, (partial and complete responses) and median progression-free survival, or PFS, in 61 evaluable patients was 62% and 9.5 months, respectively, with 48% of patients having a complete response, or CR. Patients without prior ASCT obtained high OR rates of 71%, with 55% of this subgroup of patients achieving a CR. More importantly, responses were seen across all different types of NHL and Y-90 doses. Patients with prior ASCT received lower doses, but achieved OR and CR rates of 41% and 29%, respectively.
For relapsed follicular lymphoma (FL) patients, treatment with fractionated Y-90 doses greater than 30 mCi/m2 was particularly effective, with 100% of patients responding to the treatment and 92% reporting a complete response. For the 12 complete responders who had not undergone ASCT, the median PFS was 24.6 months. Furthermore, patients with FL refractory to prior anti-CD20 containing regimens, achieved OR and CR rates of 90% (9 of 10 patients) with a median PFS of 18.3 months. The highest cumulative Y-90 fractionated dose level reported in this study was 45 mCi/m2, which is more than two-fold higher than the maximum allowable single dose of 32 mCi currently approved for ibritumomab tiuxetan.
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Immunomedics Inc. has a market cap of $219 million; its shares were traded at around $2.91 with a P/E ratio of 5.9 and P/S ratio of 7.3.
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The overall response rate (minor, partial and complete responses) in 26 evaluable patients was 69%, with 23% of patients having a complete response. Seven patients who had been diagnosed with ITP one year or less had the highest objective and complete response rates of 100% and 60%, respectively. Responses occurred across all doses tested, including the lowest dose of two times 80 mg, regardless of the route of administration. More importantly, 5 of 6 patients who have had complete responses to veltuzumab continue to maintain their increased platelet levels, with 3 patients continuing for over one year.For the 15 evaluable NHL patients reported at the conference, 53% had an objective response, and 27% had a complete response. In follicular lymphoma, 7 of 12 patients (58%) had objective responses, with 3 patients (25%) having complete responses. These findings were comparable to the Phase II results we had published using the intravenous formulation. Moreover, 7 of the 8 objective responders are currently continuing in remission, now up to 6 months after treatment. Thus, despite the small number of patients, it appears that the subcutaneous formulation of veltuzumab may be active against NHL.
In 37 evaluable patients, the disease control rate for all dose groups combined was 57%, including 6 patients (16%) with partial responses, or PR, by RECIST criteria (i.e., responses showing decreases in tumor size of more than 30% by CT and in the absence of new lesions), and 16 patients (41%) with stable disease, or SD. Most
promising efficacy was observed in the group of 16 patients that received 12 mCi/m2 of Y-90 weekly for 3 weeks, with a 69% disease control rate (19% PR and 50% SD). In addition, anecdotal reports indicated patients have good performance and decreased pain medication after treatment.
Results from a Phase I/II European study evaluating fractionated dosing of Y-90 epratuzumab tetraxetan (two or three weekly infusions of Y-90 epratuzumab tetraxetan) in 64 adult patients with relapsed/refractory NHL, including 17 patients who underwent prior autologous stem-cell transplantation, or ASCT, were recently reported in the Journal of Clinical Oncology. The overall response rate, or OR, (partial and complete responses) and median progression-free survival, or PFS, in 61 evaluable patients was 62% and 9.5 months, respectively, with 48% of patients having a complete response, or CR. Patients without prior ASCT obtained high OR rates of 71%, with 55% of this subgroup of patients achieving a CR. More importantly, responses were seen across all different types of NHL and Y-90 doses. Patients with prior ASCT received lower doses, but achieved OR and CR rates of 41% and 29%, respectively.
For relapsed follicular lymphoma (FL) patients, treatment with fractionated Y-90 doses greater than 30 mCi/m2 was particularly effective, with 100% of patients responding to the treatment and 92% reporting a complete response. For the 12 complete responders who had not undergone ASCT, the median PFS was 24.6 months. Furthermore, patients with FL refractory to prior anti-CD20 containing regimens, achieved OR and CR rates of 90% (9 of 10 patients) with a median PFS of 18.3 months. The highest cumulative Y-90 fractionated dose level reported in this study was 45 mCi/m2, which is more than two-fold higher than the maximum allowable single dose of 32 mCi currently approved for ibritumomab tiuxetan.
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