News Highlights – September 2021


September is a month with important milestones presented during ESMO and WCLC. Outstanding results from DESTINY trials paved the way for new therapeutic options and clinical standards based on Daiichi-Sankio’s conjugated MoAb ENHERTHU (trastuzumab-deruxtecan) for patients with lung, gastric and breast cancer. Impressive clinical outcomes also by IMFINZI in NSCLC (plus I/O) and in SCLC. Gilead also showed encouraging data for its anti-Trop2 conjugated antibody Trodelvy (sacituzumab-govitecan) for patients with PD-L1 positive TNBC as part of a phase III trial; while Ipsen’s Cabometyx (cabozantinib) produced a sustained response in patients with thyroid cancer.

ThermoFisher and AstraZeneca signed a partnership for the development of NGS-based CDx targeting a broad spectrum of therapies. Furthermore, Thermo’s Oncomine was granted 2 new CDx approvals: EGFR Exon 20 for NSCLC in association with Takeda’s Exkivity (mobocertinib) in the US and RET for NSCLC with Ely Lilli’s RET inhibitors in Japan. Illumina and Merck also signed an agreement to develop an HRD test for their PARPi therapies. The HRD solution is based on the Myriad test. An important advance also for melanoma patients with the approval in New York State for Castle Bioscience’s DecisionDx DiffDx, a gene profiling test for that can help with definitive diagnostics for samples with current uncertain malignant potential.

Data from the NADIM study presented at WCLC showed the predictive value of pre-treatment ctDNA levels for patients in a clinical trial setting. At ESMO, Guardant 360 Dx Liquid biopsy test consolidated its position as a key tool for treatment decisions in late-stage CRC and NSCLC. Lucence also shared data on the reliability to detect actionable mutations in patients with bladder cancer.

Still on diagnostics, the study from Robichaux and collaborators showed that not all EGFR mutations are the same and mutation profiles are directly associated with drug sensitivity levels of NSCLC patients, which can impact on clinical decision. Therefore, use of NGS can give extra support to clinicians on their decision, compared to qPCR. At ESMO, the harmonization study on PD-L1 assays for breast samples also showed a suboptimal correlation between the different tests, which poses some hurdles on the adoption of both assays in clinical routine.

Important updates of SPIRIT Guidelines for clinical research were made available, adding 14 items on patient specifications that should be collected in clinical trials, including information on molecular and digital pathology.

In Sweden, GMS will receive further SEK 220M funding to ensure their goal of universal access to high quality biomarker diagnostics. 

As for new targeted therapy regulatory decisions, they include Exelixis’ Cabometyx (cabozantinib) approval by FDA for patients with thyroid cancer refractory to radioactive iodine, Roche's Tecentriq recommendation by UK’s NICE for first-line PD-L1-Positive Bladder Cancer; and the positive opinion from EU CHMP for both Merck’s Keytruda (pembrolizumab) as a first-line treatment for metastatic PD-L1 CPS ≥ 10 TNBC and BMS’ Opdivo (nivolumab) for the treatment of HER2-negative, PD-L1 CPS ≥ 5 gastroesophageal adenocarcinomas. Finally, MHLW approved Padcev (enfortumab vedotin) for advanced urothelial cancer.

Last but not least, a milestone approval by FDA granted the first-in-history certification for Paige’s AI software applied to digital pathology, to assist the evaluation of tissue slides from prostate cancer patients. 

Summary of news (with links)


Regulatory decisions and approvals on Rx (13)



Regulatory decisions and approvals, market access and reimbursement on Dx and CDx (7)



Latest diagnostic developments, investment and CDx deals (7)



Clinical trials and drug development (38)



Observational studies (5)



Partnerships (18)


Giovanni Dothel, PhD - - Inflection Point Biomedical Advisors

Jaume Calafell - - Inflection Point Biomedical Advisors