Chicago, IL June 6, 2017 - My colleague and I spent a few days wandering around the exhibit hall at ASCO17 and got to connect with many diagnostic and research tools stakeholders and KOLs about announcements and market trends; here are the highlights of our takeaways from those discussions:Pan-tumor drugs and diagnostics

• Loxo Oncology released some of the most impressive and interesting data at the conference, showing 76% ORR for its Larotrectinib (LOXO-101) in children and adults positive for NTRK fusion proteins in a basket trial across multiple cancer types. These results come on the heels of Merck’s recent approval for Keytruda in MSI-H or dMMR patients regardless of tumor type. We think these results may be the beginning of a trend for site-of-origin-independent drug and diagnostic development strategies. The NGS-panel makers we spoke with seemed particularly excited about results like these, as the clinical validation of relatively rare molecular markers (e.g., prevalence of MSI-H, TRK-fusions <1% in many cancers, ~5% for ALK in NSCLC) may help drive the use and reimbursement of NGS panels for molecular markers earlier in the clinical paradigm.

Multiplexed biomarkers

• We continue to see a shift towards multiplexed and multi-omic biomarkers, particularly for cancer immunotherapies. Foundation Medicine and Roche Sequencing, among others, were highlighting their TMB assays. Qiagen and BMS announced a collaboration to use Qiagen’s GeneReader platform for gene-expression assays with BMS’ I/O pipeline. Company reps from NanoString explained that their Digital Spatial Profiling (DSP) technology was the hot topic around their booth, and highlighted particularly high traffic at their DSP posters. As more and more early-access customers use the platform, we are interested to see how much the spatial context adds to the value of multiplexed biomarkers. NantOmics, which had one of the bigger booths among tools and Dx players, emphasized their Cancer GPS assay, which includes WES, whole transcriptome analysis, and a ~35-protein panel expression analysis for each sample. The company rep highlighted data showing how their quantitative selected reaction monitoring mass spectrometry (SRM-MS) technology has been used in retrospective studies to establish new biomarker cutoffs that can be used as new predictive markers. For example, one study revealed a >100 fold difference in HER2 expression within HER2 IHC 3+ patients, and a new cutoff value that distinguishes “super-responders” from normal or poor responders. Another retrospective study showed how a TUBB3 cutoff of 750 amol / μg in gastric cancer tissue can be used to select patients that would not benefit for a docetaxel-containing adjuvant regimen. As clinicians seek to better understand why some patients don’t respond to certain drugs while others do, multiplexed and multi-omic biomarker platforms, as well as the establishment of more precise biomarker cutoff values, may be able to provide the nuanced insights needed for more predictive assays.

Tempus Labs

• Tempus deserves its own bullet. We were tipped-off about Tempus early during the conference by an NCI director who had toured the Tempus office earlier in the day and was blown away by what they were doing. Not many we talked to early in conference were familiar with Tempus, but those that were used phrases like: "disruptive", "explosive", "incredibly competitive and risky", and "soon challenging major service providers." Tempus is a Chicago-based diagnostic lab / health IT startup co-founded 18 months ago by Eric Lefkofsky, who also founded, among other companies, Groupon. Tempus participates in the growing space of clinical-molecular data integration. While other companies are pursuing similar or related business models (E.g., Foundation Medicine / Flatiron, Syapse) Tempus seems to have the advantage of conducting everything (testing, EMR data collection, and bioinformatics / analysis) under its own roof, as well as a personally-motivated founder with access to significant capital. By Sunday, the Tempus booth was swarming. Check out some more detailed information and insights on Tempus here.

Tumor Board Management Systems

• Another health IT trend we noticed was the emergence of IT solutions to facilitate the tumor board workflow. Roche, Syapse, and Varian were all highlighting IT systems aimed at facilitating the gathering, organizing, and presenting of data at tumor board meetings. Oncologists we spoke to indicated that, considering the increasing number of data inputs that go into patient care decisions (e.g., radiology reports, pathology reports, clinical records, the exploding number of molecular diagnostic test results, and, possibly in the future, patient-reported or mobile health data), as well as the drive to review more and more patients in a multidisciplinary setting, systems that can help facilitate the aggregation, annotation, and even analysis of all this data could save significant time and enable more productive and insightful tumor board discussions.

Liquid Biopsies

• Liquid-biopsies were front-and-center among tools and Dx players at ASCO. A lot the liquid biopsy conversations we had focused on the GRAIL / Cirina merger, which most people view as an IP consolidation play. GRAIL also showed some results of a study comparing the results of a 508-gene liquid biopsy panel using "high-intensity genomic sequencing" to results obtained in tissue from 124 patients with metastatic breast, lung, and prostate cancers. The results showed that the liquid biopsy assay, which had an average coverage depth of 60,000x(!) was able to capture 627 out of the 864 (73%) mutations found in the tissue samples, including 54 out of the 71 (76%) actionable mutations. Roche also showed some research data from its recently-announced AVENIO liquid biopsy, which comes in 17-gene, 77-gene, and 197-gene flavors. The Roche data showed that, using its 197-gene Surveillance Kit, detection of ctDNA in the blood (at 3,000 – 5,000x coverage) within 10 days after surgical resection of stage II or III colorectal cancer had a high correlation with reduced time-to-recurrence (TTR), suggesting that the assay could be used effectively to monitor MRD. The Roche reps also highlighted the ability of the 197 gene panel to be used for TMB analysis, which would make it the smallest panel, to our knowledge, that can be used as a proxy for TMB (however, we have not seen any data yet). While the liquid biopsy field looks a little cluttered at the moment, liquid-biopsy technologies appear to keep generating momentum; in the words of one rep: "We're in the NCCN guidelines. Two years ago, docs wouldn't touch a liquid biopsy, no one knew or trusted the technology. Now, we don’t see any hesitation at all."

Clinical Trial Data

• While we focused primarily on tools and diagnostics at ASCO, there were some significant trial results announced that captured a lot of attention. I'll leave it to others (here, here) to summarize the drug results, but the results that we noticed received the most buzz were LOXO’s Larotrectinib in TRK-fusion+ patients, Genentech’s Alectinib in NSCLC, Incyte’s Epacadostat / PD-1 checkpoint combos in melanoma, head and neck, and NSCLC, Nanjing Legend’s BCMA-targeted CAR-Ts in multiple myeloma, and Juno’s JCAR017 in non-Hodgkin lymphoma.

Just for fun, here is a tool to track the Twitter activity throughout the duration of the conference for the companies mentioned in this post:

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Feel free to reach out to us to discuss this blog, exchange ideas, or share your perspective on the conference, or the research tools and diagnostics industries in general. We are also happy to share / demo some of our proprietary immuno-oncology biomarker and liquid biopsy data sets.

Author: Andrew Aijian, Sr. Project Leader at DeciBio Consulting, LLCConnect with Andrew on LinkedIn:https://www.linkedin.com/in/andrewaijian/Co-Author: Mika Wang, DeciBio Consulting, LLCConnect with Mika on LinkedIn:https://www.linkedin.com/in/mikawang/About DeciBio:DeciBio Consulting is a strategy consulting and market research firm focused on the global research tools, clinical diagnostics, and health technology industries. Our mission is to provide the market intelligence and strategic insights that drive disruption and innovation in these markets. We work with clients ranging from start-ups to Fortune 500 companies, conducting custom market research and strategy assessment across all areas of the life sciences markets. Click here for more information about our consulting services.Follow DeciBio on Twitter: @DeciBioDisclaimer: Companies listed above may be DeciBio Consulting clients and/or customers