denintuzumab mafodotin (SGN-CD19A) / Pfizer - LARVOL DELTA

Treatment of Relapsed and Refractory Multiple Myeloma (PracticeUpdate) - "We don't routinely test for this. We don't have clinical assays for this, but the research work suggests, that those groups of patients appear to have an earlier, what I call now a younger, form of multiple myeloma...We also saw updates on belantamab mafodotin. There was an important study by Dr. Suzanne Trudel that looked at an alternative schedule once every eight weeks, to try to minimize some of the ocular toxicity. In combination with pomalidomide, they had pretty interesting results."

Video

Answering Your Questions: Ocular Toxicity With Antibody–Drug Conjugates (Clinical Care Options) - "Sagar Lonial, MD: Initially, the trials excluded previous therapy with a BCMA-directed treatment. However, now many trials include separate cohorts to allow prior exposure to BCMA. Both the bispecific T-cell engager and the CAR T-cell trials are allowing this, presuming the previous BCMA-targeted therapy is belantamab mafodotin because it is approved by the FDA. There is some anecdotal experience of patients responding to a BCMA-targeted bispecific T-cell engager or bispecific antibody after belantamab mafodotin and BCMA expression is not lost as a consequence of progression. So, as of now, one BCMA therapy does not necessarily preclude another, but we await further data as the trials progress."

Interview

Seattle Genetics announces more than 20 presentations at ASH 2015 highlighting progress with broad ADCETRIS (brentuximab vedotin) development plan and multiple antibody-drug conjugate (ADC) pipeline programs (Businesswire) - "ADCETRIS data featured in 17 presentations, including eight oral presentations, support goal to establish ADCETRIS as the foundation of therapy for CD30-expressing malignancies; Clinical data for SGN-CD33A (vadastuximab talirine) and SGN-CD19A (denintuzumab mafodotin) ADC programs to be highlighted in oral presentations."

Anticipated clinical data • Anticipated conference • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

Seattle Genetics to present clinical data from broad ADCETRIS (brentuximab vedotin) development program and novel antibody-drug conjugate (ADC) SGN-CD19A at ASH 2013 (Seattle Genetics Press Release) - "The presentations at ASH demonstrate the breadth of [Seattle Genetics'] development program for ADCETRIS in CD30-positive malignancies, including frontline and relapsed patients and disease areas ranging from Hodgkin lymphoma to mature T-cell lymphoma and diffuse large B-cell lymphoma....[The company] continue to make progress in advancing...robust ADC pipeline, including SGN-CD19A, which is currently being evaluated in ALL and aggressive non-Hodgkin lymphoma."

Conference • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

Seattle Genetics reports third quarter 2014 financial results (Businesswire) - "...financial strength and clinical development progress in the third quarter were marked by record ADCETRIS net sales, up 32 percent from the third quarter of 2013...[Seattle Genetics is] positioned for a strong presence at the upcoming ASH annual meeting with 18 abstracts accepted for presentation... [including] additional data from the AETHERA trial....[The company] will also report interim phase 1 data at ASH from SGN-CD33A and SGN-CD19A...."

Anticipated conference • Anticipated P1 data • Anticipated P3 data • Sales • Hematological Malignancies • Oncology

Seattle Genetics highlights data from denintuzumab mafodotin (SGN-CD19A) antibody-drug conjugate program at ASH 2015 (Seattle Genetics Press Release) - "...'Data presented at ASH from our 19A phase 1 trial in non-Hodgkin lymphoma show encouraging objective response rates, particularly in relapsed DLBCL patients, and a tolerability profile that we believe supports further investigation as part of novel regimens. Based on these data, we recently initiated a phase 2 trial in relapsed DLBCL, and plan to initiate a phase 2 trial in frontline DLBCL during 2016'..."

Anticipated new P2 trial • Conference • P1 data • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

Seattle Genetics presents data from phase 1 clinical trial of antibody-drug conjugate (ADC) SGN-CD19A in non-Hodgkin lymphoma at ASCO Annual Meeting (Seattle Genetics Press Release) - P1, N=37; "...the objective response rate observed was 30 percent (11 patients). Six patients (16 percent) achieved a complete remission, five (14 percent) achieved a partial remission, 13 (35 percent) had stable disease and 13 (35 percent) had progressive disease as best response."

P1 data • Clinical oncology content • Non-Hodgkin’s Lymphoma • Oncology

Seattle Genetics presents data from novel antibody-drug conjugate (ADC) SGN-CD19A at ASH 2013 (Seattle Genetics Press Release) - "Seattle Genetics..presented interim phase 1 clinical data from SGN-CD19A, an antibody-drug conjugate (ADC) in development for the treatment of B-cell malignancies, including acute lymphoblastic leukemia (ALL), at the 55th American Society of Hematology (ASH) Annual Meeting and Exposition taking place in New Orleans, Louisiana, December 7-10, 2013. SGN-CD19A is an ADC targeting CD19, a protein expressed uniformly on almost all B-cell malignancies."

P1 data • Acute Lymphocytic Leukemia • Oncology

Novel therapy for relapsed childhood acute lymphoblastic leukemia (EHOC 2019) - "In the more intensive re-induction British protocol (ALL-R3), Mitoxantrone and Idarubicin were compared, and it was observed that Mitoxantrone resulted in significant increases in both overall survival and progression-free survival rates due to the reduction of the relapse rate. The BFM (Berlin-FrankfurtMünster) group administered a more intensive re-induction treatment by adding medium-dose Methotrexate and high-dose Cytarabine to the 4-drug chemo combination...Although the response rate was 44% in the phase 2 Clofarabine + Cyclophosphamide study performed in the previously intensively treated group, there was no benefit in the COG study containing Clofarabine + high dose Cytarabin (Ara-C) in the second or more recurrent ALL cases...The COG group demonstrated that the addition of Nelarabine to high-risk T-ALL treatment based on the BFM treatment scheme had an acceptable toxicity (mostly peripheral neuropathy) and observed an uneventful survival rate higher in the..."

Clinical • IO Biomarker • BCL2 • CDK6

Preclinical activity of the antibody-drug conjugate denintuzumab mafodotin (SGN-CD19A) against pediatric acute lymphoblastic leukemia xenografts. (PubMed, Pediatr Blood Cancer) - "Denintuzumab mafodotin showed single-agent activity against selected B-lineage ALL PDXs, although leukemia growth was evident in most models at 28 days from treatment initiation. This level of activity for denintuzumab mafodotin is consistent with that observed in adults with ALL."

Journal

NEW DRUGS FOR NON‐HODGKIN LYMPHOMA: BEYOND CHEMOTHERAPY: NEW DRUGS FOR OLD TARGETS (ICML 2019) - P1, P1/2, P1a/1b, P1b, P1b/2, P2, P2/3, P3; "...Ofatumumab was approved for patients with chronic lymphocytic leukemia (CLL) at different lines of treatment of this disease, alone or in combination, but failed to demonstrate a benefit and to gain approval in phase 3 studies performed in combination with chemotherapy in relapsed diffuse large B-cell lymphoma (DLBCL) (NCT01014208) or as single agent in patients with relapsed/refractory (R/R) follicular (FL) or other indolent lymphoma (NCT01200589)...In a randomized study comparing bendamustine single agent versus bendamustine combined with obinutuzumab and followed by obinutuzumab maintenance in patients who were assessed as refractory to rituximab, the experimental arm resulted in significant progression free survival (PFS) and overall survival (OS) benefits.6 The GALLLIUM phase 3 study7 demonstrated a significant improvement of PFS in combination with chemotherapy in untreated patients with FL, while no benefit was observed in the