ASH 2013: Meeting highlights from Takeda, Roche, Novartis and Gilead

9 December 2013

The 55th American Society of Hematology (ASH) meeting began in New Orleans on Saturday with a host of large pharma companies presenting data from their latest clinical trials. Abstracts included the following:

Millennium, the US oncology unit of Japan’s largest drugmaker Takeda Pharmaceutical (TSE:4502) announced results from a retrospective, subgroup analysis of the Phase III VISTA study that showed a higher cumulative dose of Velcade (bortezomib) suggests improved overall survival in previously untreated patients with multiple myeloma. Patients who received a cumulative dose of Velcade of 39mg/m² or greater lived 20 months longer on average than those who received lower cumulative doses (median OS 66.3 months and 46.2 months, respectively). Velcade is approved by the US Food and Drug Administration for the treatment of MM and relapsed mantle cell lymphoma (MCL).

Swiss drug major Roche (ROG: SIX) presented data from a Phase III study with GA101, a first-of-its-kind targeted cancer antibody. Results from the CLL11 study show that patients with chronic lymphocytic leukemia (CLL) and co-existing medical conditions experienced nearly a year of extra remission time when treated with GA101 in combination with chlorambucil, compared with MabThera(rituximab) and chlorambucil. An updated analysis from the first stage (stage 1a) of the CLL11 study, which compared GA101 plus chlorambucil with chlorambucil alone, was also presented. GA101 increased the likelihood of being alive by 59% when used with chlorambucil chemotherapy versus chlorambucil alone for patients with CLL and co-existing medical conditions.

Swiss drug major Novartis (NOVN: VX) highlighted new research on the investigational chimeric antigen receptor (CAR) therapy, CTL019, which add to the scientific understanding of CTL019 in the treatment of acute lymphoblastic leukemia (ALL) and chronic lymphocytic leukemia and build on earlier research findings. Highlights of the presentations include findings that 19 of 22 pediatric patients with ALL (86%) experienced complete remissions. The first pediatric patient treated with the protocol remains in remission 20 months later. Additionally, all five of the first adult ALL patients treated to date have experienced complete remissions, the longest of which continues six months after treatment.

Novartis also presented findings from three large, randomized Phase III studies that demonstrate the superiority of Tasigna (nilotinib) compared to Glivec (imatinib) at achieving deeper molecular responses across various Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) patient populations. The data includes newly-diagnosed patients, patients with residual disease who switched to Tasigna after long-term treatment with Glivec, and patients who failed to respond to frontline Glivec. The ENESTnd data indicate a trend for longer overall survival and event-free survival in newly diagnosed Ph+ CML patients on Tasigna versus Glivec. Data also demonstrated higher rates of early and deeper molecular response in newly diagnosed patients, including MR4.5, and a reduced risk of progression. The separate study, ENESTcmr, confirms treatment with Tasigna led to deeper molecular response in patients who switch after long-term treatment with Glivec.

Gilead Sciences (Nasdaq: GILD) announced results of a Phase II study (Study 101-09) evaluating idelalisib, an investigational oral inhibitor of PI3K delta, for the treatment of patients with indolent non-Hodgkin's lymphoma (iNHL) that is refractory (non-responsive) to rituximab and to alkylating-agent-containing chemotherapy. In this study, single-agent treatment with idelalisib achieved an overall response rate of 57% with a median duration of response of 12.5 months. Of the 71 patients who responded to therapy, seven (6%) achieved a complete response, 63 (50%) had a partial response and one (1%) had a minor response.

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