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Lymphocytic Leukemia, Acute

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November 3, 2014

Novartis and the University of Pennsylvania’s Perelman School of Medicine reported results of two pilot trials evaluating CTL019 in patients with relapsed/refractory acute lymphoblastic leukemia (r/r ALL). Twenty-five patients enrolled in the pediatric pilot trial and five patients enrolled in the adult pilot trial. The study found 27 of 30 pediatric and adult patients with r/r ALL (90%) experienced complete remissions, including two blinatumomab-refractory patients and 15 with prior stem cell transplant. Of the 27 patients who achieved a complete remission, five went off-study for alternate therapy, three of whom proceeded to allogeneic SCT in remission. Fifteen patients remain in remission with a median follow-up of seven months. Sustained remissions were achieved up to two years with six-month, event-free survival 67% (95% CI, 51% to 88%) and overall survival 78% (95% CI, 65% to 95%). The probability of six-month CTL019 persistence was 68% (95% CI, 50 to 92%) and relapse-free B cell aplasia was 73% (95% CI, 57 to 97%). CTL019-modified T cells were detectable in the blood by flow cytometry for up to 11 months, and CTL019 sequences remained detectable by quantitative PCR (Q-PCR) in patients with sustained remissions for up to two years.

November 12, 2012

MorphoSys and Xencor released results from a phase I/IIa trial of MOR208 (MOR00208/XmAb5574) for the treatment of tumor activity. This dose-ranging study enrolled patients with high-risk, heavily pretreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Subjects received doses ranging from MOR208 0.3mg/kg to 12mg/kg as an intravenous infusion on days 1, 4, 8, 15 and 22 in cycle one, and on days 1, 8, 15 and 22 in cycle two. Overall response rate by International Working Group on CLL (IWCLL) 2008 criteria was 11%, which utilizes more rigorous CT scan reduction of internal lymph nodes not previously required in older historic studies. Using IWCLL 1996 response criteria resulted in a response rate of 42%. MORE208 was well tolerated and found safe. The most frequent adverse events were mild to moderate infusion reactions usually with the first dose. Based on these results, MorphoSys plans to commence phase II studies of MOR208 in B-cell malignancies in the near future.

June 21, 2010

Micromet issued positive results from a phase II trial of blinatumomab for minimal residual disease (MRD) positive acute lymphoblastic leukemia (ALL). This trial enrolled 21 subjects who had sub-microscopic evidence of leukemic cells in the bone marrow following treatment with front-line chemotherapy (minimal residual disease). The subjects received 15 micrograms per meter squared per day of blinatumomab for 28 days followed by two weeks off therapy over a six week treatment cycle. The primary endpoint was MRD response. Of 20 evaluable patients, 80% achieved a complete MRD response. Among 13 non-transplanted patients, there were eight with non-Ph+ or t(4;11) disease. For these eight subjects the median time to hematological relapse has not been reached at a median follow-up of 480 days. Six of nine evaluable, MRD responding, non-transplanted patients were in hematologic remission, ranging up to 23 months. Eight of the subjects received an allogeneic transplant after blinatumomab treatment, all of whom are alive and in remission, ranging up to 21 months. Overall, blinatumomab was well-tolerated.