News Highlights – April 2022

02/05/2022

This spring opened with a number of compelling progresses in the adoption of diagnostics, especially in Europe.

Genetron Health obtained CE Mark for its Seq-MRD for patients with B lymphocytic leukemia and multiple myeloma before and after treatment. Lunit obtained CE mark for its Lunit Scope PD-L1 TPS, an AI-based test to analyze PD-L1 expression in both tumor and inflammatory cells from whole slide images of IHC-stained tumor tissues. Paralelly, Paige earned both CE-IVD and UKCA marks for Paige Breast Lymph Node, an AI medical device software that helps pathologists detect breast cancer metastases in lymph nodes. In addition, Agilent expanded CE-IVD mark in the European Union for its PD-L1 IHC 28-8 pharmDx to identify patients with esophageal squamous cell carcinoma eligible for BMS’s Opdivo (nivolumab) plus chemotherapy or Opdivo in combination with Yervoy (ipilimumab). The CE-IVD mark was also granted for the selection of patients with muscle-invasive urothelial carcinoma (MIUC) harboring tumor cell PD-L1 expression ≥ 1% for treatment with Opdivo (nivolumab).

This month also witnessed partnerships to promote the development of new diagnostic tools and CDx: Illumina announced a long-term strategic partnership with Janssen Biotech to co-develop CDx programs based on Illumina's TruSight Oncology Comprehensive assay; AmoyDx entered into several collaborations starting with AstraZeneca to develop and commercialize in China, Japan and the European Union CDx tests covering any type of indication or biomarker, including gene mutations leading to homologous recombination repair (HRR) deficiency in patients with prostate cancer. In the EU, AmoyDx and AstraZeneca are partnering to develop CDx for BRCA gene mutations in breast cancer patients. Still AmoyDx signed two strategic cooperations: with Hutchmed to develop a CDx in China for Osimertinib/Savolitinib combined treatment in NSCLC; and with Beckman Coulter Life Sciences to develop new applications on the Biomek NGeniuS Next Generation Library Prep System, an automatic liquid handler for NGS library preparation.

Moreover, a number of agreements were signed to promote patients' access to molecular testing. NeoGenomics announced a collaboration with Eli Lilly to provide free of charge genomic testing using NeoGenomics' NeoType DNA and RNA Assay for eligible metastatic NSCLC patients. Texas Oncology will use its precision oncology clinical pathways tool to enable test ordering of Foundation Medicine’s FoundationOne Liquid CDx Liquid Biopsy Test.

As for studies on the application of NGS in diagnostics, new data were presented by Pillar Biosciences showing high accuracy of its oncoReveal Dx Lung & Colon Cancer Assay for the detection of clinically relevant variants (KRAS G12/G13, EGFR L858 and exon 19 deletion, and BRAF V600E). Likewise, Guardant Health presented new data showing a high sensitivity rate of Guardant SHIELD multi-cancer assay to detect early-stage CRC and lung cancer.

Coming to drugs’ approval, Bristol Myers Squibb’ Opdivo (nivolumab) received EMA’s authorization as adjuvant treatment for patients with muscle-invasive urothelial carcinoma at a high risk of recurrence after surgery with PD-L1 expression ≥1% in tumor cells. The same approval was granted to Opdivo (nivolumab) and Yervoy (ipilimumab) combined with chemotherapy for patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma with PD-L1 expression ≥1% in tumor cells. In addition, Astellas Pharma and Seagen received EMA’s approval for PADCEV (enfortumab vedotin) as monotherapy for locally advanced or metastatic urothelial cancer patients.

EMA also approved Merck’s Keytruda (pembrolizumab) plus chemotherapy, with or without bevacizumab, for patients with persistent, recurrent or metastatic cervical cancer with expression of PD-L1 (CPS ≥1), and as monotherapy for patients with Microsatellite Instability-High (MSI-H) or Deficient Mismatch Repair (dMMR) tumors for five different cancer types. In addition, Merck received a positive opinion from EU CHMP for Keytruda (pembrolizumab) plus chemotherapy as neoadjuvant treatment, then in continuation as monotherapy as adjuvant treatment for patients with locally advanced, or early-stage TNBC at high risk of recurrence.

In U.S, FDA granted Breakthrough Therapy Designation to Enhertu (fam-trastuzumab deruxtecan-nxki) for patients with HER2-low (IHC 1+ or IHC 2+/ISH-negative) metastatic breast cancer, and Fast Track Designation to ONC-392, a next-generation anti-CTLA-4 monoclonal antibody, for metastatic NSCLC patients. Finally, the Chinese NMPA approved tislelizumab as 2L for patients with esophageal squamous cell carcinoma.

Stay tuned for more updates on Precision Oncology and connect with us for a deeper dive on key advancements in specific countries.

Summary of news (with links)

Regulatory decisions on Rx (21)

 




Dx approvals, market access and reimbursement (8)

 



Latest diagnostic developments, investment and CDx deals (7)

 




Clinical trials and drug development (14)

 




Observational studies (5)

 

 

Merge and acquisitions (2)

 



Partnerships (12)

 

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

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