News Highlights – May 2021


May marks an important milestone for long unmet needs for cancer patients: Amgen’s sotorasib (Lumakras), the first KRAS G12C monoclonal for advanced NSCLC, and Janssen’s amivantamab-vmjw (Rybrevant) for the treatment of NSCLC with EGFR exon 20 insertion mutations received a fast track approval by FDA . While Qiagen's Therascreen KRAS RGQ PCR is the CDx for KRAS tissue analysis, Guardant’s Guardant360 CDx is its CDx counterpart for liquid biopsy and the sole CDx to date for amivantamab-vmjw. Approvals with liquid biopsy will have a direct impact on the testing pathway in routine and reimbursement, especially in Europe and Japan.

Still on liquid biopsy, Vall d’Hebron Institute and the Leicester Cancer Research Centre have published the results from their collaborative study describing how blood ctDNA can discern cancer DNA signatures from early stage to metastasis, while Lucence is embarking on a validation study of its liquid biopsy test LiquidHALLMARK for the detection of actionable mutations in NSCLC patients.FoundationOne, has been approved as CDx for BridgeBio Pharma and Helsinn Group's infigratinib (Truseltiq) for use in locally advanced or metastatic cholangiocarcinoma with a positive FGFR2 fusion, making its second approval for the indication after Incyte’s pemigatinib (Pemazyre).

Immunotherapies also kept the momentum with multiple approvals in May, including Roche’s atezolizumab (Tecentriq, 1st line monotherapy treatment for metastatic NSCLC patients), BMS’ nivolumab (Opdivo, adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer) and Merck’s pembrolizumab (Keytruda, combo with trastuzumab and chemotherapy as first-line treatment in locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma). The latter, in addition, received NICE recommendation for metastatic MSI-high, mismatch repair-deficient colorectal cancer.

Digital platforms and the use of AI for diagnostics is seeing increasing investments, with the UK eastern Region financing the newly formed Early Diagnostic Institute to develop 5 blood tests based on machine learning algorithms for the early screening of cancer and chronic diseases. Additionally, Mindpeak’s AI-based solution for cell quantification in breast cancer received CE-mark and Quest Diagnostics and Paige have formed an alliance to provide a range of AI solutions applied to the whole patients management path: from diagnosis, through AI-assisted digital pathology, to self-care, through digital healthcare softwares.
Summary of news (with links)


Regulatory decisions on Rx (11)


Dx approvals, market access and reimbursement (6)


Latest diagnostic developments, investment and CDx deals (13)


Clinical trials and drug development (29)


Observational studies (3)


Merge and acquisitions (6)


Partnerships (16)


Giovanni Dothel, PhD - - Inflection Point Biomedical Advisors

Jaume Calafell - - Inflection Point Biomedical Advisors