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Nov 30, 2018
 |  BioCentury  |  Product Development

Cell therapy momentum at ASH

A survey of clinical abstracts at ASH 2018 highlights momentum in CAR Ts

This year’s American Society of Hematology (ASH) meeting will showcase a surge in clinical CAR T cell presentations. But gene therapies are not following the same trajectory, despite both modalities being fresh off their first approvals.

In advance of the meeting, which will be held Dec. 1-4 in San Diego, BioCentury applied a series of manual and algorithm-guided analyses of the abstracts, and identified 2,209 that involve clinical studies of therapeutics, diagnostics or prognostic biomarkers.

Cell therapy coverage rises dramatically this year, predominantly in cancer indications. The number of abstracts covering cell therapies for cancer almost doubled from 66 last year to 116 this year. In hematology, the count increases to 14 from 11 (see “Figure: ASH 2018 Cancer Modalities”).


Figure: ASH 2018 cancer modalities

While the near-doubling from 2017 in clinical abstracts describing cell therapies to treat cancer at the 2018 American Society of Hematology (ASH) meeting reflects continued interest in CAR T therapies, other modalities also have seen more trials and new indications this year, especially multispecific antibodies, which grew across a wide range of cancer types. One modality -- antisense oligonucleotides (ASOs) -- had its first-ever clinical abstract at ASH, with trials in acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS). BioCentury searched abstracts for select modalities identified as therapeutically relevant using BCIQ: BioCentury Online Intelligence and abstracts were curated for therapeutic context. The analysis includes some double counting as some abstracts contained multiple indications. Source: ASH abstracts as of Nov. 1, 2018

BioCentury’s analysis of the 2,146 preclinical abstracts at the meeting uncovers the same trend, suggesting cell therapies will continue to flood clinical pipelines in the coming years (see “Revving up Metabolism at ASH 2018”).

The rise in clinical studies of cell therapies is driven by CAR T cell research, which is discussed in 94 abstracts, up from 46 in 2017 (see “Figure: ASH 2018 Cancer Cell Therapy Types”).


Figure: ASH 2018 Cancer cell therapy types

While the number of abstracts describing clinical cell therapies to treat cancer increased from the 2017 to the 2018 meetings of the American Society of Hematology (ASH), the growth was almost entirely due to CAR T cells, which were by far the most popular therapeutic cell type in both years. Acute lymphoblastic leukemia (ALL) and B cell lymphomas, the approved indications for marketed CAR T products Kymriah tisagenlecleucel and Yescarta axicabtagene ciloleucel, remain most prominent, but activity in other indications grew dramatically in 2018, led by multiple myeloma (MM), which was the subject of 16 CAR T abstracts, up from four CAR T and one NK cell abstract in 2017. BioCentury searched abstracts for select cell types identified as therapeutically relevant using BCIQ: BioCentury Online Intelligence and curated abstracts for therapeutic context. The analysis includes some double counting as some abstracts contained multiple indications. Source: ASH abstracts as of Nov. 1, 2018

Surprisingly, while all eyes are on tumor necrosis factor receptor superfamily member 17 (BCMA; TNFRSF17; CD269) CAR T cell therapies as one of the next most advanced targets for the modality, these are not the primary drivers of the uptick. Instead, the increase reflects companies developing an array of new cell constructs and multispecific targeting strategies, reanalyzing CD19 data and branching out into new indications (see “Figure: ASH 2018 Clinical Phases for New Modalities”).


Figure: ASH 2018 clinical phases for new modalities

Most of the abstracts describing clinical trials of new modalities at the 2018 American Society of Hematology (ASH) meeting show studies in Phase I or Phase I/II testing. For cell therapies, such trials can support regulatory filings, as was the case for accelerated approval of CAR T therapies Kymriah tisagenlecleucel and Yescarta axicabtagene ciloleucel from Novartis AG (NYSE:NVS; SIX:NOVN) and Gilead Sciences Inc. (NASDAQ:GILD), respectively. The analysis includes both cancer and non-cancer indications. BioCentury searched abstracts for select modalities identified as therapeutically relevant using BCIQ: BioCentury Online Intelligence and abstracts were curated for therapeutic context. “Other studies” include post-marketing studies, pooled analyses of multiple trials, compassionate use data and trials where a phase could not be determined. Phase I/II includes “pilot” trials. Trial phases were determined from abstract text and from trial numbers corresponding to listings on ClinicalTrials.gov, European Clinical Trials Database (EudraCT), and the Chinese Clinical Trial Registry (ChiCTR). ASO = antisense oligonucleotide; Source: ASH abstracts as of Nov. 1, 2018, ClinicalTrials.gov, EudraCT, ChiCTR

By contrast, gene therapy abstracts for hematology indications fall to 14 from 17 last...

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