Epizyme reported "positive, mature data" at the 2019 American Society of Hematology Annual Meeting from its ongoing Phase 2 trial of tazemetostat, an oral EZH2 inhibitor, as a monotherapy for patients with follicular lymphoma, both with or without EZH2 activating mutations, who have received at least two prior lines of systemic therapy. The data show that treatment with tazemetostat demonstrated "meaningful" clinical activity as assessed by both investigators and an Independent Review Committee, and was generally well tolerated in both FL patients with EZH2 activating mutations and FL patients with wild-type EZH2, the company said. The IRC assessment was conducted for inclusion in Epizyme's planned NDA submission to the Food and Drug Administration in December 2019. As assessed by the IRC, as of an August 9, 2019 data cutoff date, tazemetostat treatment resulted in: Objective response rate of 69% for patients with an EZH2 mutation and 35% for patients with wild-type EZH2; Median duration of response of 11 months for patients with an EZH2 mutation and 13 months for patients with wild-type EZH2; Median progression-free survival of 14 months for patients with an EZH2 mutation and 11 months for patients with wild-type EZH2; Overall survival has not yet been reached for either FL patient. "Follicular lymphoma remains an incurable disease today, and it's essential that patients be able to receive treatment for an extended period of time," said Dr. Shefali Agarwal, Chief Medical Officer of Epizyme. "We believe the clinically meaningful benefit of tazemetostat seen across both FL patient populations in this trial, along with its continued tolerability, are impressive findings. We are particularly pleased with the robust response rates, extended durability and consistency of data as assessed by investigators and independent reviewers. These data support tazemetostat's potential to make a difference for FL patients, and we look forward to submitting our NDA for both patient populations later this month."

Corvus Pharmaceuticals announced initial results from its Phase 1/1b trial of CPI-818, the company's ITK-inhibitor. The early clinical data from the study demonstrated specific target engagement by CPI-818, the company said. The CPI-818 Phase 1/1b study is currently enrolling patients with several types of advanced, refractory T-cell lymphomas, including peripheral T-cell lymphoma, angioimmunoblastic T-cell lymphoma, cutaneous T-cell lymphoma and other T-cell lymphomas. Seven patients have been enrolled in the first two dose cohorts in the initial phase of the trial, receiving a 100 mg or 200 mg oral dose of CPI-818 two times per day, with no dose limiting toxicities and no grade 3 or 4 adverse events observed. The results from the pharmacokinetic and occupancy studies for the first seven patients have been in-line with expectations. The company anticipates that a dose that achieves maximum target occupancy will be achieved in the next one or two dose cohorts. CPI-818 has been shown to bind covalently to ITK at low nanomolar concentrations without reacting with other kinases, it added.

AbbVie announced results of a 7.5-year pooled analysis showing earlier treatment with Imbruvica monotherapy compared to later lines of therapy extended progression-free survival and increased the likelihood of a complete response in patients with relapsed/refractory mantle cell lymphoma - "demonstrating that some patients achieved a disappearance of any signs of disease." The updated pooled analysis includes three clinical trials: Phase 2 SPARK, Phase 3 RAY and Phase 2 PCYC-1104. Patients achieving a CR with Imbruvica "had a strong response, with a median duration of therapy longer than 5.5 years" the company said.

Sangamo Therapeutics (SGMO) and Pfizer (PFE) announced updated follow-up results from the Phase 1/2 Alta study evaluating investigational SB-525 gene therapy in patients with severe hemophilia A. The data showed that SB-525 was generally well tolerated and demonstrated sustained increased Factor VIII levels following treatment with SB-525 through to 44 weeks, the extent of follow-up for the longest treated patient in the 3e13 vg/kg dose cohort, the companies said.. Data from 11 patients treated with SB-525 will be featured in a poster presentation today at the Annual Meeting of the American Society of Hematology. In the 3e13 vg/kg dose cohort, patients achieved normal range FVIII activity within 5-7 weeks of treatment with SB-525, the companies added. "We are pleased with the progress that we have made in progressing SB-525 gene therapy toward a Phase 3 registrational study, including enrolling the first patient in the 6-month lead-in study. We expect to dose the first patient in the Phase 3 registrational study in 2020," said Seng Cheng, Senior Vice President and Chief Scientific Officer of Pfizer's Rare Diseases Research Unit. "We continue to believe that if the observed safety and efficacy results are sustained, this gene therapy has the potential to transform the treatment paradigm of severe hemophilia A."

Genentech, a member of the Roche Group, announced new data on two investigational CD20-CD3 T-cell engaging bispecific antibodies, mosunetuzumab and CD20-TCB, in people with relapsed or refractory B-cell non-Hodgkin's lymphoma. Results from the Phase I/Ib GO29781 study of mosunetuzumab, including data from people previously treated with chimeric antigen receptor T-cell therapy, will be presented at the 61st American Society of Hematology 2019 Annual Meeting. The GO29781 study evaluated mosunetuzumab in patients with R/R NHL, including patients who have relapsed following, or are resistant to, CAR T-cell therapy. Results from this dose-escalation study showed "encouraging efficacy" with an objective response rate of 62.7% in slow-growing NHL and 37.1% in aggressive NHL. Additionally, data demonstrated a complete response rate of 43.3% in slow-growing NHL and 19.4% in aggressive NHL. CRs showed durability, with 82.8% of patients with slow-growing NHL remaining in remission up to 26 months off initial treatment and 70.8% of patients with aggressive NHL, remaining in remission up to 16 months off initial treatment, the company added. Of the participants who received prior CAR T-cell therapy, the ORR was 38.9%, and 22.2% achieved a CR. Adverse reactions included cytokine release syndrome in 28.9% of patients with 20.0% at Grade 1 and 1.1% at Grade 3. Grade 3 neurological adverse events occurred in 3.7% of patients, Genentech said.

Cellular Biomedicine Group announced early data from its ongoing investigator initiated trial (at an oral presentation titled "Novel Anti-BCMA CAR-T for Relapsed or Refractory Multiple Myeloma" at the American Society of Hematology annual meeting. A Phase 1, dose escalation trial is being conducted in patients with relapsed or refractory multiple myeloma to assess the safety and efficacy of C-CAR088. As of the end of November the company has enrolled eleven patients, of which eight were infused with C-CAR088, and five patients were evaluable for clinical response. Three of the five patients were treated with C-CAR088 at the dose of 1.0 x 106 CAR-T cells/kg, and the other two patients treated at 3.0x106 CAR-T cells/kg. All five patients showed clinical improvement as early as two weeks post treatment, Cellular Biomedicine said in a statement. By four weeks, one patient achieved a complete response, three patients reached a very good partial response, and one patient reached a partial response post C-CAR088 infusion, the company said. Furthermore, Cellular Biomedicine observed that C-CAR088 proliferation and expansion in the peripheral blood correlated with the decrease of tumor burden in all patients. C-CAR088 treatment showed to be well tolerated, it added.

AbbVie announced results from an extended follow-up analysis of the Phase 3 E1912 clinical study - designed and conducted by the ECOG-ACRIN Cancer Research Group and sponsored by the National Cancer Institute. Study results showed superior progression-free survival and overall survival in patients with chronic lymphocytic leukemia new to treatment, the company said. These results demonstrated the benefits of Imbruvica plus rituximab compared to a standard chemoimmunotherapy regimen of fludarabine, cyclophosphamide and rituximab for previously untreated patients with chronic lymphocytic leukemia aged 70 years or younger. Additionally, a new integrated analysis of up to six years of long-term follow-up from the Phase 3 Resonate and Resonate-2 studies will be presented on December 8 at the American Society of Hematology Annual Meeting, evaluating the use of Imbruvica monotherapy in previously untreated patients. Results showed better progression-free survival, overall survival and overall response rate, with good tolerability compared to use in the relapsed/refractory setting, according to AbbVie. At a median follow-up of 48 months, 73% of patients in the Imbruvica plus rituximab treatment arm remained on Imbruvica with median time on treatment of 43 months. The median time to progression or death after discontinuing Imbruvica was 23 months.