News
Company News: Micromet Presents Promising New Data on Anti-Cancer BiTE® Antibody Blinatumomab
Micromet has presented promising new data from two clinical trials with its lead BiTE® antibody, blinatumomab, at the 53rd American Society of Hematology (ASH) Annual Meeting in San Diego, CA. Blinatumomab is the first of a new class of agents called BiTE® antibodies, designed to harness the body’s T cells to kill cancer cells. The compound is being developed for the treatment of leukemia and B cell lymhoma.
The data show that Micromet’s blinatumomab more than doubled the complete remission rate produced by current standard therapies used to treat adult patients with relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL).
In a phase 2 single-arm dose-ranging trial, 68% of evaluable patients (17/25) across all tested doses and schedules achieved a complete response (CR) or complete response with partial hematologic recovery (CRh*) following treatment with blinatumomab. Of the 12 evaluable patients who received the selected dose and schedule 75% (9 of 12) achieved a CR or CRh*. Notably, all responders also achieved a molecular response, or in other words, had no evidence of remaining leukemic cells detectable in the blood or bone marrow.
A first interim analysis of the time impact of blinatumomab treatment was conducted for the initial 18 patients enrolled to the trial. The median survival had not been reached, with a median follow-up period of 9.7 months. With combination chemotherapy, median survival typically ranges from 3 – 6 months1-5. 12 of the initial 18 patients had a CR or CRh* with a median duration of response of 7.1 months. Based on the results of this study, the Company initiated a global phase 2 study in this patient population in November 2011.
Moreover, new findings from a phase 1 trial presented at the meeting demonstrate Micromet’s blinatumomab induces durable responses in patients with extensively pre-treated diffuse large B cell lymphoma (DLBCL).
Data focused on a cohort of 13 patients with DLBCL, of which 11 received the target dose and were evaluable for response. Of these 11 patients, 6 (55%) achieved an objective response following treatment with blinatumomab. 4 of 11 patients (38%) achieved a complete response. Patients were treated with a single course of blinatumomab induction therapy for up to eight weeks. As of October 2011, 5 of 6 patients had ongoing responses for up to 16.6 months. The median duration of response had not been reached with a median observation time of 7.1 months.
All patients enrolled in this study had received prior rituximab-containing regimens. Most had received three or more prior lines of therapy, including 8 of 13 patients with prior autologous stem cell transplant.
Company News: MediGene Presents Overall Survival Data from a Phase II Trial of EndoTAG®-1 in Triple-Negative Breast Cancer (TNBC)
– Positive efficacy trend of EndoTAG®-1/Paclitaxel combination therapy confirmed
– Subgroup analysis reveals encouraging overall survival data with EndoTAG®-1 plus paclitaxel combination therapy
MediGene AG today announced median overall survival data from its phase II trial of EndoTAG®-1 for the treatment of triple-negative breast cancer (TNBC), which was presented at the San Antonio Breast Cancer Symposium in San Antonio, USA. The secondary endpoint data confirm the positive efficacy trend of EndoTAG®-1 in combination therapy with standard weekly paclitaxel, which was previously reported by the primary endpoint data (progression-free survival rate at 16 weeks). Furthermore, an additional analysis of a subgroup of patients not predefined in the study protocol (119 of 140 patients: ECOG 0/1, first-line therapy for advanced cancer) showed encouraging overall survival data with EndoTAG®-1/paclitaxel combination therapy. The data were presented by Prof. Dr. Ahmad Awada, principal investigator of this trial and Head of the Medical Oncology Clinic at Jules Bordet Institute in Brussels, Belgium.
140 patients diagnosed with TNBC participated in the phase II clinical trial. Patients were randomized to three groups and received either EndoTAG®-1 in combination with weekly paclitaxel (55 patients) or EndoTAG®-1 monotherapy (57 patients). The third group (28 patients) only received weekly paclitaxel. The patients treated with combination therapy received 22 mg/m2 EndoTAG®-1 plus 70 mg/m2 paclitaxel once per week. EndoTAG®-1 monotherapy was administered twice per week, in a dosage of 44 mg/m2 per treatment. The paclitaxel monotherapy consisted of a once weekly 90 mg/m2 dose. The clinical trial was conducted in more than 30 centers in several European countries and in India. The study was not powered for intergroup comparisons.
Median overall survival time (as at reference date “visit week 41” of the last patient treated) for those 133 patients with TNBC status confirmed by central lab was 13.0 months in the EndoTAG®-1/paclitaxel combination therapy arm (51 patients), 11.9 months in the EndoTAG®-1 monotherapy arm (57 patients), and 10.1 months in the paclitaxel monotherapy arm (25 patients). Further data analysis of this group was done for those 124 patients treated per protocol. Median overall survival in this group was 15.1 months in the EndoTAG®-1 combination therapy arm (48 patients), 12.5 months in the EndoTAG®-1 monotherapy arm (52 patients), and 8.9 months in the paclitaxel monotherapy arm (24 patients).
Additionally, MediGene analyzed a subgroup of patients that was not predefined in the study protocol. This included patients with centrally confirmed TNBC status, ECOG performance status of 0/1 at the start of the clinical trial and who received first-line treatment after tumor relapse (119 patients). Median overall survival in this group was 17.8 months in the EndoTAG®-1 combination therapy arm (45 patients), 11.7 months in the EndoTAG®-1 monotherapy arm (50 patients), and 10.1 months in the paclitaxel monotherapy arm (24 patients).
Data regarding the primary endpoint of the trial (progression-free survival rate at week 16), the secondary endpoints progression-free survival rate, clinical benefit rate, and best overall response, as well as safety and tolerability of EndoTAG®-1 have previously been published and are available at http://www.medigene.de/presse_en/endotagTNBC.
Innovation Radar: Brilliant Mistakes – Finding Success on the Far Side of Failure
Everybody knows of instances in their own life where initial “mistakes” or wrong decisions turned out to be exactly the right thing. Trivial examples include going to a party that you never really wanted to attend and ending up meeting the person of your life – or running ten minutes late and thereby avoiding a fatal car crash that had just occured down the road.
But what about the most carefully managed area in life – your own career and business? Thinking that wrong business decisions must mean the end of your career? The opposite may be the case, says Paul J.H. Schoemaker, research director of Wharton’s Mack Center for Technological Innovation and chairman and founder of consulting firm Decision Strategies International.
In his book Brilliant Mistakes: Finding Success on the Far Side of Failure, Schoemaker argues that mistakes often open the door to totally new perspectives and findings – and help you reinvent your business or personal career for good. Mistakes have been the basis for many innovations that revolutionized the way we live today – including the discovery of penicillin and the development of ATM machines.
Knowledge@Wharton features an interview with Paul J.H. Schoemaker, who talks about the concept of brilliant mistakes – i.e. ignoring conventional wisdom at the time – and the innovative potential of this approach. Being risk averse, he says, is not going to take businesses very far and will kill their productivity and their ability to adapt to new markets and opportunities. Instead, both executives and researchers should be able to learn from surprises and turn failures into successes by looking at them from a totally different angle.
Certainly an interesting concept for anyone working in an industry that is characterized by decreasing productivity, lack of true innovation and stagnation – e.g. the pharmaceutical sector. After all, cost-cutting and consolidation have not emerged as effective means to spur innovation.
Company News: Keeping an Eye on Micromet
The human immune system is one of the body’s most powerful weapons to combat cancer, and therefore a lot of companies are working to activate it against tumors, writes Siegfried Hofmann in Handelsblatt this week. As an example, he features the BiTE antibodies developed by Micromet, Inc. These BiTE antibodies bind to T cells and subsequently to specific tumor antigens on cancer cells. Thereby, the T cells are activated and start destroying the tumor cells. The first drug candidate is in late-stage clinical development to treat Leukemia, Hofmann writes. The article is also being featured in the internet version of Wirtschaftswoche.
Micromet recently started a Phase 2 trial of its lead product blinatumomab (MT103) in relapsed/refractory acute lymphoblastic leukemia (ALL), a very difficult to treat disease. If initial results generated from this trial are compelling, Micromet plans to discuss with the FDA potential avenues to accelerate blinatumomab’s path to market. Blinatumomab is also being tested for the treatment of non-Hodkin’s Lymphoma (NHL). In addition, the company announced it hired Joseph Lobacki as Senior Vice President and Chief Commercial Officer. Previously, Lobacki was Senior Vice President and General Manager, Transplant and Oncology at Genzyme. Christian Itin, CEO of Micromet said “his extensive sales, marketing and medical affairs experience will be critical as we look to prepare the marketplace for blinatumomab’s potential launch.”