News Highlights – March 2022

01/04/2022

This month confirms a focus of companies and institutions on precision medicine to advance patients' testing and treatments, with more and more opportunities made available throughout the entire globe.

The Spanish Societies of Oncology and Pathology issued an official claim to the NHS for the coverage of biomarker testing and to establish reference centers for NGS in the National territory. FDA released new guidelines for clinical trials design including indication to speed up the approval process for cancer drugs and biologicals.

Several approvals of CDx and targeted therapies have been granted from East to West. In China, NMPA approved Burning Rock’s LungCure CDx, while in Japan, PMDA granted the approval to Guardant Health for Guardant360 CDx, a liquid biopsy test for solid tumors. EpiCheckBladder, a further LB test by Nucleix was included in this year’s clinical guidelines of the European Association of Urology (EAU) for non-muscle invasive bladder cancer (NMIBC). In the US, a milestone Rx-CDx approval was granted by FDA with Myriad’s BRACAnalysis CDx along with Astrazeneca and Merck’s Lynparza (olaparib) for the treatment of patients with early BC presenting BRCA germline mutation. In addition, FDA granted FoundationMedicine an approval for FoundationOne CDx to select patients with EGFR therapies targeting Exon 19/Exon 21 mutations in NSCLC. In addition, Guardant Health obtained local medicare coverage for its Guardant360 tissueDx.

Regarding developments in diagnostics, Illumina launched a new test for comprehensive genomic profiling in Europe. Moreover, Invitae added a new blood test in its Personalized Cancer Monitoring (PCM) platform, to detect minimal residual disease (MRD) in patients with solid tumors. Castle Bioscience’s DecisionDx®-Melanoma test showed to overcome standard T-Stage analysis in patients with cutaneous melanoma, according to an independent study.

In the field of AI and diagnostics, there have been several announcements impacting both clinics and research. Genomenon finalized a second round of financing of its gene data hub for the implementation of a broad range of AI applications for clinical decisions and research purposes. Roche will collaborate with BMS and PathAI, leveraging clinical trial settings and anatomic pathology laboratories with machine-learning solutions. Fabric Genomics announced a collaboration with MIT and Harvard to develop an AI-assisted clinical WGS system for clinical testing and reporting. Likewise, PathAI and Cleveland Clinic agreed for a 5-year partnership to implement AI solutions in translational research and routine diagnostics. Within a similar collaboration, Genomics England will apply Insitro’s AI-based algorithms to integrate histopathology analysis, genomic and clinical data.

As for clinical trials, Merk’s Keytruda (pembrolizumab) showed improvement of Distant Metastasis-Free Survival (DMFS) as adjuvant therapy in resected stage IIB and IIC melanoma. In a different study Keytruda significantly improved Disease-Free Survival (DFS) in patients with stage IB-IIIA NSCLC. Merck also announced the interruption of a phase 3 trial on Keytruda combined with lynparza (olaparib) for no outcome differences with control arm in patients with metastatic castration-resistant prostate cancer. Recent data published on NEJM showed that HER2-positive metastatic breast cancer patients previously receiving trastuzumab plus taxane, had a lower risk of progression or death from any cause with trastuzumab-deruxtecan vs trastuzumab-emtansine. Gilead Sciences ‘s Trodelvy (sacituzumab govitecan-hziy) improved progression-free survival (PFS) of patients with HR+/HER2- metastatic breast cancer who received prior endocrine therapy, CDK4/6 inhibitors and 3 to four lines of chemotherapy.

Among this month's approvals for targeted therapies, NMPA authorized Beigene’s Tislelizumab for the treatment of patients with solid tumors and high microsatellite instability or mismatch repair deficiency. In addition, FDA approved BioPharma’s Vonjo (pacritinib) for the treatment of patients with myelofibrosis and severe thrombocytopenia.

Summary of news (with links)

Institutional announcements and guidelines updates (3)

 

 

Regulatory decisions on Rx (5)

 




Dx approvals, market access and reimbursement (7)

 



Latest diagnostic developments, investment and CDx deals (7)

 




Clinical trials and drug development (14)

 




Observational studies (2)

 




Partnerships (8)

 

  

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

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