ASH 2015 roundup: Amgen, MorphoSys, Novartis and Roche present new trial data
pharmafile | December 8, 2015 | News story | Research and Development | Amgen, Cancer, Novartis, Roche, ash, morphosys, oncology
Amgen
Amgen presented data from three Phase II trials evaluating Blincyto (blinatumomab) in acute lymphoblastic leukemia (ALL)- a rare and rapidly progressing cancer of the blood and bone marrow.
In a Phase 2 confirmatory multicenter single-arm trial (BLAST) of adult patients with B-cell precursor ALL with minimal residual disease (MRD), who received Blincyto monotherapy, median relapse-free survival (RFS) was 18.9 months.
“A key goal in the treatment of blood cancers is to prevent relapse from occurring,” says Sean Harper, executive vice president of Research and Development at Amgen. “Achieving a complete minimal residual disease, or MRD response, is important because having no detectable MRD places ALL patients at a lower risk for relapse when compared to patients with persistent or recurrent MRD. The data presented are highly encouraging because they support the potential of Blincyto in a broader spectrum of ALL patients, including those at an earlier stage of disease.”
MorphoSys
– MOR202
German biotech MorphoSys published phase 1/2a trial data on its MOR202 candidate- a HuCAL antibody targeting CD38, in the treatment of multiple myeloma (MM).
The trial is assessing MOR202 as a monotherapy and in combination with the immunomodulatory drugs (IMiDs) pomalidomide and lenalidomide plus dexamethasone.
Data from the 52-patient study showed MOR202 was safe and well tolerated with a two-hour infusion time, with a very low incidence of infusion-related reactions- mainly limited to the first infusion. In this heavily pre-treated patient population, MOR202 demonstrated encouraging responses with a best-in-class tolerability profile.
In the monotherapy group, three of nine patients achieved an objective response rate, with the other six patients showing stable disease. In the early combination cohorts at 8 mg/kg MOR202 with IMiDs, one of six patients saw very good partial response. Two partial responses and one minimal response (MR) were reported.
In upcoming cohorts, patients will receive 16 mg/kg MOR202 in combination with pomalidomide (POM) and lenalidomide (LEN) plus dexamethasone. In addition, confirmatory cohorts are planned to validate the recommended dose of MOR202 as monotherapy and in combination with POM/Dex and LEN/Dex.
-MOR 208
The company also provided an update on its potent anti-CD19 antibody MOR208, which is being developed to treat B cell malignancies.The data are from a phase 2a monotherapy study of patients with different subtypes of relapsed or refractory Non-Hodgkin’s Lymphoma (NHL) and another Phase II study where MOR208 is tested in chronic lymphocytic leukemia (CLL) in combination with lenalidomide.
The open-label, phase 2a, multicenter study was designed to assess the activity and safety of single-agent MOR208 in patients with diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), and other indolent NHL (iNHL), who had received at least one prior rituximab-containing therapy.
The data for the NHL phase 2a monotherapy study of 92 heavily pre-treated patients show MOR208 is well tolerated with a low level of infusion reactions and encouraging single-agent activity. The overall response rate was 28% across all four subtypes of NHL and reached 36% in the DLBCL subgroup (both based on evaluable patients).
At the time of the analysis, several responders – 9 out of 21 – had an ongoing response to the single agent treatment. Median progression-free survival for all subtypes of NHL tested in the study amounted to six months. The longest response duration observed so far exceeded 20 months in both DLBCL and FL.
Novartis
The Swiss company announced positive results from the global Phase III RATIFY trial of patients with newly-diagnosed FLT3-mutated acute myeloid leukemia (AML), who received the investigational compound PKC412 (midostaurin) plus standard induction and consolidation chemotherapy.
These patients experienced a 23% improvement in overall survival (OS) compared to those treated with standard induction and consolidation chemotherapy alone, with a median OS of 74.7 months versus 25.6 months for patients in the placebo group.
The trial evaluated the addition of either PKC412 (midostaurin) or placebo to daunorubicin/cytarabine in the induction phase, followed by high-dose cytarabine in the consolidation phase; patients who achieved complete remission after consolidation chemotherapy continued treatment with PKC412 (midostaurin) or placebo as a single agent for up to one year
Novartis also presented findings from an ongoing Phase IIa study to evaluate its investigational chimeric antigen receptor T cell (CART) therapy CTL019 in certain types of relapsed or refractory (r/r) non-Hodgkin lymphoma.
The study found an overall response rate (ORR) at three months of 47% (7/15) in adult patients with r/r diffuse large B-cell lymphoma (DLBCL) and an ORR of 73% (8/11) in adult patients with follicular lymphoma (FL)
The study found that three patients with DLBCL who achieved a partial response (PR) to treatment at three months converted to complete response (CR) by six months. In addition, three patients with FL who achieved a PR to treatment at three months converted to CR by six months.
One DLBCL patient with a PR to treatment at three months experienced disease progression at six months after treatment. One FL patient with a PR to treatment at three months who remained in PR at nine months experienced disease progression at approximately 12 months after treatment. Median progression-free survival (PFS) was 11.9 months for patients with FL and 3.0 months for patients with DLBCL.
Finally, Novartis announced today that five-year treatment with Jakavi (ruxolitinib) suggested an overall survival advantage for patients with myelofibrosis (MF), despite crossover to Jakavi from the best available therapy arm after the primary analysis at 48 weeks. In the Phase III COMFORT-II study, more than half of the patients with MF (53.4%) also experienced significant reductions (>=35%) in spleen size with Jakavi therapy, and sustained this benefit for an average of 3.2 years.
Roche
New results from the CLL11 study show Gazyva/Gazyvaro (obinutuzumab) provided people with previously untreated chronic lymphocytic leukaemia a treatment-free period of 51.1 months, including the six month initial treatment period.
Roche said Gazyva/Gazyvaro, in combination with Leukeran (chlorambucil), reduced the risk of disease worsening or death by more than half compared to Rituxan (rituximab) plus Leukeran, with median PFS of 28.7 months versus 15.7 months.
Elsewhere, subsidiary Genentech announced new, positive data from the Phase II M13-982 study of Venetoclax, an investigational medicine being developed in partnership with AbbVie.
Results of the study showed a clinically meaningful reduction in the number of cancer cells (overall response rate, ORR) in 79.4 percent of people with previously treated (relapsed or refractory) chronic lymphocytic leukemia (CLL) with 17p deletion.
In addition, 7.5% of people achieved a complete response with or without complete recovery (complete response without normal blood counts) in the bone marrow (CR/CRi).
At one year, 84.7% of all responses and 94.4% of MRD-negative responses were maintained. The one-year progression-free survival (PFS) and overall survival (OS) rates were 72% and 86.7%, respectively.
Joel Levy
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