News Highlights – May 2022

02/06/2022

There were several highlights in May about new approvals for targeted treatments, deals for companion diagnostics and updates on drug development. May 26 was the due-date for in vitro medical devices to meet criteria of the new European IVD regulation. A day circled in red by diagnostic companies undergoing product certification, since low-risk IVDs have been postponed depending on class risk: for class-D products, 2025; C, 2026; B 2027.

Also this month, a guinness-sized prospective trial on NGS by Agendia reached 10.000 of breast cancer patients enrolled in the FLEX registry for a large-scale observational study of Real World Data to discover new genomic profiles in breast cancer. In addition, Agendia demonstrated the equivalence in terms of cost-effectiveness of their decentralized NGS services, Mammaprint and Blueprint compared to local microarray analysis. Likewise, Illumina and AHN are partnering to explore predictive genetic variations by Comprehensive Genomic Profiling (CGP) in an in-house vs an external setting. In addition, BC platforms, Euformatics and Oncompass Medicine joined forces to provide an NGS-based workflow to a consortium of seven hospitals based in Europe.

As for latest updates on liquid biopsy, Delfi Diagnostics entered into a research agreement with Memorial Sloan Kettering Cancer Center to further develop its liquid biopsy platform and translating it into clinics. Moreover, Guardant Health’s liquid biopsy test service was made available to patients with solid tumors at Vall d’Hebron Institute of Oncology in Barcelona, allowing the Comprehensive Gene Profile test for the detection of actionable mutations. Lucence announced the publication of data validating its ​​LiquidHALLMARK test to detect ctDNA in the majority of cancer patients and 70% of lung cancer patients. Still on lung cancer, Qiagen launched therascreen EGFR Plus RGQ PCR Kit for the test of both activation and resistance-related mutational variants of EGFR from tissue and liquid biopsy of patients with non-small cell lung cancer (NSCLC). Finally, the CE mark was granted to SeekInClarity Cancer Treatment Response Monitoring Kit by SeekIn, a combined strategy to test mutational tumor burden (MTB) by whole-genome sequencing (sWGS) and protein analysis (PTMs) from patients’ blood samples.

The CE-mark was also secured by Precipio for its HemeScreen panel for the test of hematologic malignancies by NGS; whereas Illumina announced the addition of a new indication as companion diagnostic (CDx) to its CE-marked TruSight Oncology (TSO) Comprehensive (EU) test to select cancer patients with solid tumors who are positive for neurotrophic tyrosine receptor kinase (NTRK) gene fusions, and eligible for the treatment Bayer's Vitrakvi (larotrectinib).

This month’s regulatory provisions for drug compounds include FDA’s approved Bristol Meyer Squibb’s Opdivo (Nivolumab) in two combinations of chemotherapy, as well as Serier’s Tibsovo (ivosidenib) plus Azacitidine in patients with newly diagnosed IDH1-mutated Acute Myeloid Leukemia. In Europe, Merck’s Keytruda (pembrolizumab) was approved, combined with chemotherapy as neoadjuvant, then continued after surgery as adjuvant monotherapy in locally advanced or early-stage Triple-Negative Breast Cancer at high risk of recurrence. In addition, Keytruda received positive EU CHMP opinion as adjuvant for adult and adolescent (≥12 Years of Age) patients with stage IIB or IIC melanoma following complete resection. Parallely, Agilent’s PD-L1 IHC 22C3 pharmDx received the CE mark.

There were also remarkable investments in the field of precision oncology. MOMA Therapeutics closed a second round of financing for the development of new drug targets based on key enzymes’ conformational changes. Verastem Oncology was granted with the first “Therapeutic Accelerator Award” by the Pancreatic Cancer Network to support a Phase 1b/2 clinical trial of VS-6766, plus defactinib in patients with front-line metastatic pancreatic cancer.

Various clinical developments of targeted therapies for lung cancer this month included: Sugemalimab, an anti-PD-L1 antibody, showing favorable results as a consolidation therapy in patients with unresectable stage 3 NSCLC without disease progression after concurrent or sequential chemoradiotherapy; Oritinib, a third generation TRK inhibitor, provided a high disease control and objective response rates in the treatment of EGFR-T790M+ NSCLC patients. Camrelizumab+chemotherapy as first line therapy, improved overall survival of patients with advanced NSCLC. As for breast cancer, a refinement of the combined treatment with Bevacizumab plus hormonal therapy showed better outcomes in patients with metastatic ER+/HER2- Breast Cancer; Trodelvy (Sacituzumab govitecan-hziy) maintained clinical response regardless of patients’ HER2 expression.

If you look for a more in-depth view on precision oncology or for a better understanding of country-related healthcare features, do not hesitate to reach out to us!

Summary of news (with links)

 

Regulatory decisions on Rx (12)

 



Dx approvals, market access and reimbursement (6)

 



Latest diagnostic developments, investment and CDx deals (8)

 



Clinical trials and drug development (14)

 



Observational studies (1)

 




Merge and acquisitions (1)

 



Partnerships (3)

 

 

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

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