An aggressive malignancy, Glioblastoma is an indication with one of the highest level of unmet need in oncology. Currently, Avastin and Temozolomide dominates the market. With GBM market estimated to reach $3.3B (G7 market) by 2024 (Globaldata), companies are trying out novel approaches.
GBM pipeline is characterized by active early stage assets with ability to block either one pathway or multiple pathways at the same time. Also, combination therapies are being developed leveraging novel drug with standard treatments.
This year in ASCO, we will see some positive readouts from early stage.
The phase Ib/II study (by Boston Biomedical) demonstrated Napabucasin to be safe when combined with temozolomide, showing encouraging anti-tumor activity in recurrent Glioblastoma pts.
The Phase 1b study highlights of the oncolytic adenovirus DNX-2401 ± Interferon Gamma (from DNAtrix, Inc) looks positive & will be presented in ASCO. This is encouraging news for DNAtrix, who are also trying multiple combinations of DNX-2401; the most notable being the CAPTIVE study – analysing the potential impact of DNX-2401 and KEYTRUDA in patients with rGBM
The market had been anticipating good news in the immunotherapy front. But the recent failure of Phase 3 Opdivo (CM 143) has caused initial setback. Astrazeneca will be presenting data from an ongoing Phase 2 trial of durvalumab. The Durva monotherapy appears to be well tolerated and shows durable activity in a subset of BEV-naïve recurrent GBM pts.
AbbVie will show positive Phase 1 data for ABT-414 (ADC targetting EGFR) in EGFR-amplified rGBM. This is again encouraging for AbbVie, which is also conducting a global, randomized Phase 2 trial of ABT-414 vs. ABT-414 + TMZ vs. TMZ/lomustine in EGFR amp pts (results expected later this year).
Novartis will discuss about Ribociclib, which is in early Phase 1 for treatment of patients with rGBM. Novartis’s Ribociclib has received FDA approval as 1L treatment for HR+/HER2- metastatic breast cancer on Mar 2017.
Another GBM related highlights for ASCO 2017 is the large retrospective study (including 1165 pts) by Cleveland clinic, which add to the growing body of evidence supporting the use of aggressive treatment (chemo- radiation) to prolong OS for elderly GBM patients. The efficacy and imaging analyses of the ARTE trial rejects the hypothesis that the addition of bevacizumab to radiotherapy improves outcome in elderly patients with newly diagnosed glioblastoma.
Some other notable positive readouts:
Ad-RTS-hIL-12 (INXN-2001) With Veledimex – Ziopharma
TPI 287 + Avastin – TPI 287 + Avastin
Tanibirumab (TTAC-0001) – PharmAbcine / 3SBIO
Results of some of the trials that are awaited:
VAL-083 in patients with chemo-resistant glioblastoma – Delmar Pharma [Phase 1]
AZD1775 (Wee1 kinase inhibitor) in combination with RT/TMZ – Astrazeneca [Phase 1]
Regorafenib / Stivarga (oral multi-kinase inhibitor) – Bayer [Phase 2] – final analysis expected on Dec 2017
Preeti has been with RAS since its inception in 2014. She has worked on several projects involving strategy development, competitive intelligence and market analysis. She is passionate about data which she combines with her natural knack for visualisation and creating engaging content. Preeti began her career with a Masters Degree in Biotechnology from University of Abertay