News Highlights – February 2022

01/03/2022

This February witnessed an update for the EU Parliament for the Fight Against Cancer Plan, several collaborations for CDx developments, as well as new Dx launches, especially for IVD tests for early-stage cancer.

AmoyDx partnered with Pierre Fabre to develop a CDx in China to detect BRAF mutation in tumor samples and select patients eligible for Braftovi (encorafenib) with or without Mektovi (binimetinib). Genetron Health and Hutchmed partnered to develop a CDx in China for Hutchmed’s Orpathys (savolitinib), a lung cancer TKI. In addition, Foundation Medicine announced an agreement with Eli Lilly to develop Foundation Medicine’s tissue- and blood-based assays (FoundationOneCDx and FoundationOneLiquid CDx) as CDx for Retevmo (selpercatinib) and other therapies in Loxo Oncology at Lilly’s pipeline. Foundation Medicine also received FDA approval for FoundationOneCDx as a CDx for Keytruda (pembrolizumab) to identify MSI-H in patients with solid tumors; as well as a Breakthrough Device Designation for its ctDNA monitoring assay FoundationOneTracker, to detect MRD in early-stage tumors. Paralelly, SeekIn received CE marking for its SeekInCare Cancer Detection Kit, a DNA-based blood test for early pan-cancer detection.

Also this month, the European Parliament adopted an updated framework with an allocation of 4 billion €, to strengthen Member States’ commitment in fighting cancer as well as giving indications on plans and economic dispositions. The update also highlighted the need for additional preventive measures; for making cancer diagnostics more accessible and affordable at EU level, by extending joint procurement procedures to include companion diagnostics; and for enabling a better access to cross-border health care and clinical trials, among others.

Moreover, new Dx tests were made available in Europe. Invitae launched FusionPlex Dx and LiquidPlex Dx, two NGS panels to test solid tumors in tissue and blood samples, respectively. Reveal Genomics launched in Spain its HER2DX genomic test, to predict the risk of HER2+ breast cancer recurrence and the likelihood of treatment response. Still in Europe, Ophiomics and Biocartis entered into a collaboration to commercialize HepatoPredict, a prognostic CE-marked IVD test that estimates the risk of liver cancer recurrence; while Mainz Biomed continued with its partnerships within Germany to commercialize its ColoAlert test, this time with Laboratory Mönchengladbach MVZ Dr. Stein & Kollegen. In France, Illumina partnered with the Jean Perrin Center at the Clermont-Ferrand University Hospital to assess the clinical value of CGP for late-stage cancer patients. The evidence will then be used to support precision medicine approaches within the French healthcare system.

Moreover, Cleveland Diagnostics presented a real-world study reinforcing the clinical utility of IsoPSA, a blood-based test detecting prostate-specific antigen (PSA) to assess the risk of prostate cancer; whereas Veracyte released data from Phase 3 NRG/RTOG 0126 study which validated clinical utility of its Decipher Prostate Genomic Classifier to help guide treatment selection in patients with intermediate risk of prostate cancer.

Regarding novel targeted therapies in oncology, the AEMPS in Spain approved the first european-developed CAR T-cell therapy for the treatment of acute lymphoblastic leukemia (ALL) resistant to conventional treatments in patients older than 25. In addition, the EMA approved Merck’s Tepmetko (tepotinib) as monotherapy for patients with advanced NSCLC harboring METex14 skipping alterations, whereas the Japanese MHLW approved Keytruda (pembrolizumab) plus Lenvima (lenvatinib) for radically unresectable or metastatic RCC. Merck also presented new data for Keytruda (pembrolizumab) from the Phase 3 KEYNOTE-522 trial, showing to prolong event-free survival (EFS) in patients with high-risk early-stage TNBC. In turn, Phase 3 DESTINY-Breast04 Trial on Daiichi Sankyo and AstraZeneca’s Enhertu (trastuzumab deruxtecan) improved both PFS and OS in Patients with HER2-Low metastatic BC. Finally, Phase 3 CheckMate -9ER Trial on BMS’ Opdivo (nivolumab) with cabozantinib showed sustained survival benefits and health-related quality of life (HRQoL) improvements after 2-year follow-up for 1L advanced RCC.

Summary of news (with links)

 

Institutional announcements (1)

 

Regulatory decisions on Rx (5)

 



Dx approvals, market access and reimbursement (3)

 

 


Latest diagnostic developments, investment and CDx deals (13)



Clinical trials and drug development (13)

 



Observational studies (4)

 




Merge and acquisitions (1)

 



Partnerships (12)

 

Giovanni Dothel, PhD - gdothel@ipbadvisors.com - Inflection Point Biomedical Advisors

Jaume Calafell - jcalafell@ipbadvisors.com - Inflection Point Biomedical Advisors