June 12, 2017
Takeda Pharmaceutical and Seattle Genetics reported results of a phase III trial of Adcetris (brentuximab vedotin) in patients with cutaneous T-cell lymphoma (CTCL). ALCANZA is a randomized, open-label study designed to evaluate single-agent ADCETRIS versus a control arm of investigator’s choice of the standard of care therapies methotrexate or bexarotene. The objective response lasting at least four months (ORR4), as assessed by Global Response Score, was 56.3% in the ADCETRIS arm compared to 12.5% in the control arm (p=<0.0001). Key secondary endpoints specified in the protocol, including complete response rate, progression-free survival and reduction in the burden of symptoms during treatment (Skindex-29), were all highly statistically significant in favor of the Adcetris arm. The safety profile associated with Adcetris from the ALCANZA trial was generally consistent with the existing prescribing information. The most common adverse events of any grade include peripheral neuropathy, nausea, diarrhea, fatigue, vomiting, alopecia, pruritis, pyrexia, decreased appetite and hypertriglyceridemia. Based on the study results, Takeda plans to begin to submit data from the ALCANZA trial to regulatory agencies in its territories in 2017. The FDA granted Breakthrough Therapy Designation to ADCETRIS for the treatment of the most common subtypes of CTCL, mycosis fungoides (MF) and primary cutaneous anaplastic large cell lymphoma (pcALCL). Seattle Genetics plans to submit these data as part of a supplemental Biologics License Application to the FDA in mid-2017. The ALCANZA trial received a Special Protocol Assessment (SPA) agreement from the FDA and scientific advice from the EMA.
February 3, 2014
Janssen has issued positive results of a
phase II study of siltuximab for the treatment
of Multicentric Castleman’s Disease
(MCD) in subjects who are HIV-negative and
human herpes virus-8 (HHV-8)-negative. The
multi-national, randomized, double-blind,
placebo-controlled study involved 79 subjects
randomized 2:1 to receive either siltuximab
plus best supportive care (BSC) or placebo plus
BSC until protocol-defined treatment failure,
after which patients taking the placebo could
cross over to un-blinded siltuximab. Half of
the patients on placebo (13 out of 26) crossed
over to siltuximab. The study found more
than one-third of patients in the siltuximab
arm had a durable tumor and symptomatic
response to treatment, compared to none of
the patients who received placebo plus BSC
(34% v. 0%). In looking at the response rate to
treat MCD-related symptoms, 25% of patients
who received siltuximab plus BSC had durable
complete symptom resolution, defined as
100% reduction of baseline overall symptom
scores for at least 18 weeks, compared to none
of the patients who received placebo plus BSC.
These data supported the recent regulatory
filings of siltuximab in the U.S. and E.U.
December 17, 2012
Senesco Technologies released interim results from an ongoing phase Ib/IIa trial of SNS01-T for the treatment of multiple myeloma, mantle cell (MCL) and B-cell lymphoma (DLBCL). This open-label, multiple-dose, dose-escalation study enrolled two patients so far with relapsed or refractory multiple myeloma. Subjects received SNS01-T or 0.0125mg/kg per dose intravenously, while the next three arms will receive SNS01-T or 0.05mg/kg, 0.2mg/kg or 0.375mg/kg per dose intravenously. Blood levels of monoclonal (M)-protein were measured using serum protein electrophoresis. Data showed patients 41-002 and 42-002 in cohort 1, serum levels of M-protein remained within 25% of the baseline values (3.60g/dL, 3.0g/dL respectively) at weeks three (3.90g/dL, 2.8g/dL) and six (4.20g/dL, 2.8g/dL), stable disease. For patient 42-002, M-protein stayed within 25% of baseline at week 10 (3.2g/dL)—four weeks after the end of treatment. M-protein levels for patient 43-001 increased from baseline to week three by 26% and from baseline to week six by 30%. Indicative of the partial disappearance of cancer cells, the plasma cell levels for patients 41-002 and 42-002 declined from 70% to 50% and from 50% to 15%, respectively. Plasma cell levels for patient 43-001 increased from 70% at baseline to 97% at end of treatment. Based on these data, Senesco Technologies will continue to dose patients in the other three arms.
May 23, 2011
CureTech released preliminary results from a phase II trial of CT-011 for Diffuse Large B Cell Lymphoma (DLBCL). This open label trial enrolled 72 subjects with DLBCL following autologous stem cell transplantation. The subjects received three intravenous infusions of 1.5 mg/kg of CT-011 every six weeks and were then followed for 13 months. The primary endpoint was progression-free survival within 16 months following the first CT-011 treatment compared to historical control. Preliminary analyses indicated that 70% of the subjects treated with CT-011 were progression-free at the end of the follow-up period, as compared to 47% in the historical control. In addition, 84% of the subjects treated with CT-011 were alive by the end of the follow-up period, compared to 62% in the historical control.
December 1, 2008
Transgene issued positive interim data from a phase II trial of TG1042, an immunotherapy for the treatment of cutaneous B-cell lymphoma (CBCL). This non-controlled, open label, two stage trial is underway in the US, France and Switzerland. Stage 1 enrolled 13 subjects who were treated with intra-lesional injections of 5 x 1010 viral particles of TG1042 per lesion, three times a month, for up to four months. The primary objective, to reach eight responding patients out of 13, was reached. Out of the 12 evaluable subjects, 10 presented an objective response. Of these 10 subjects, five showed a complete response and five presented a partial response. The remaining two subjects were stable under treatment. TG1042 was well tolerated. The most frequent adverse effects were moderate injection-site reactions and transient fever.