Posted by on December 9th, 2016.
The American Society of Hematology, a 58-year-old organization of hematologists, wrapped up its 2016 annual meeting in San Diego this week. The conference features many of the biggest names in the pharmaceutical and biotech industries and serves as a platform to announce new drugs, clinical trial results and initiatives for the future. ASH 2016 was the biggest meeting ever and is the largest hematology meeting in the world, with over 27,000 in attendance this week.
Some of the key data highlights of ASH 2016 are outlined below.
Abbvie was closely watched at ASH for how they planned to pivot from blockbuster Humira’s pending patent expiration to expanding their oncology portfolio. Venclexta (venetoclax) is one arm in that strategy, with trials across hematological malignancies run by both Roche and Abbvie. Among AMLpatients unfit for high dose anthracycline-containing chemotherapy, venetoclax plus LDAC has been demonstrated as a safe and effective regimen. (In the phase 2 study, 14 of 20 treated patients achieved a complete response. Median OS was not reached but estimated to be 75%).
Roche faces a similar dilemma in planning for Rituximab’s (rituxan) patent expiry by attempting to pivot to Gazyva (obinutuzumab). In an interim analysis of the Phase 3 GALLIUM trial in first line FL, Gazyva plus chemotherapy demonstrated a significant increase in 3-year PFS compared to Rituximab plus chemotherapy (82% vs. 78%, HR 0.71, p=0.01). However, lack of a significant difference in OS, a higher rate of grade 3 adverse events and rapidly approaching biosimilars may limit physician enthusiasm to convert to Gazyva in FL.
CAR-T therapy is an exciting field of study, with multiple companies unveiling data at ASH, including KITE, Juno, Bluebird, Novartis and Poseida. KITE and Juno’s anti-CD19 agents released strong data in heavily pre-treated NHL patients (KITE CR 6/6; Juno CR 8/11). Bluebird’s anti-BCMA in MMwas presented at EORTC the week before ASH (ORR 8/9, CR 1/9). Additional CAR-T data was released by Novartis and Poseida.
In the hot field of Immunotherapy, both Keytruda (pembrolizumab) and Opdivo (nivolumab) presented dozens of abstracts across hematology at ASH. One of the more game-changing advances combined nivolumab and azacitidine in relapsed AML patients. The combination achieved surprisingly strong results given the typically poor prognosis that patients face (CR 18%, mOS 9.3 mo, n=35). The addition of pembrolizumab to pomalidomide and dexamethasone in heavily pretreated MM patients also demonstrated comparatively strong data (ORR 56%, VGPR 13%, n=48).
Questions remain around how physicians, patients and payers will choose between the growing number of treatment options. For now though, ASH 2016 was an exciting whirlwind of advances aimed at improving standard of care across indications.