News Highlights – May 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.
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Summary of news (with links)
Regulatory decisions on Rx (12)
- In Vitro Diagnostic Medical Devices Regulation enters into full effect
- European Commission approves Cabometyx® as a second-line treatment for people living with radioactive iodine-refractory differentiated thyroid cancer
- Imfinzi Plus Chemotherapy Granted Priority Review in the US for Patients With Locally Advanced or Metastatic Biliary Tract Cancer Based on TOPAZ-1 Phase III Trial
- BeiGene Announces the Approval in China of BLINCYTO® (Blinatumomab) for Injection for Pediatric Patients with Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia (ALL)
- Elpiscience Announces FDA IND Clearance of ES014, a First-in-Class Anti-CD39xTGF-β Bispecific Antibody for Patients with Advanced Solid Tumors
- Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) as Adjuvant Treatment for Adult and Adolescent (≥12 Years of Age) Patients With Stage IIB or IIC Melanoma Following Complete Resection
- European Commission Approves KEYTRUDA® (pembrolizumab) Plus Chemotherapy as Neoadjuvant Treatment, Then Continued as Adjuvant Monotherapy After Surgery for Locally Advanced or Early-Stage Triple-Negative Breast Cancer at High Risk of Recurrence
- FDA Approves Two Nivolumab Combinations Unresectable Advanced ESCC
- Servier Announces FDA Approval of TIBSOVO® (ivosidenib tablets) in Combination with Azacitidine for Patients with Newly Diagnosed IDH1-mutated Acute Myeloid Leukemia
- Elevation Oncology Announces FDA Fast Track Designation Granted to Seribantumab for the Tumor-Agnostic Treatment of Solid Tumors Harboring NRG1 Gene Fusions
- FDA Grants Priority Review to Mirvetuximab Soravtansine in FRα-High Platinum-Resistant Ovarian Cancer
- FDA Grants Breakthrough Therapy Designation to Repotrectinib for ROS1+ Metastatic NSCLC
- FDA Grants Orphan Drug Designation to Darovasertib for Uveal Melanoma Treatment
Dx approvals, market access and reimbursement (6)
- Agilent Companion Diagnostic Expands CE-IVD Mark in Europe to Include Cervical Cancer
- First Guardant Health Liquid Biopsy Testing Service in Europe Now Operational at Vall d’Hebron Institute of Oncology
- Precipio Receives CE-IVD Certification To Market Multiple HemeScreen® Panels In Europe
- Illumina Introduces New Pan-Cancer Companion Diagnostic to Match Patients with Rare Genetic Mutations to Targeted Therapy
- SeekIn Receives CE Mark Approval for SeekInClarity™ Cancer Treatment Response Monitoring Kit
- INEX Innovate receives European CE-IVD Certification for its OvaCis® Rapid Test
Latest diagnostic developments, investment and CDx deals (8)
- Agendia Achieves Historic Milestone of Enrolling 10,000 Patients in FLEX, the Largest-Ever Prospective, Real-World-Evidence Trial for Patients With Early Stage Breast Cancer
- Agendia Demonstrates Accessibility and Affordability of MammaPrint® and BluePrint® in Europe at ESMO Breast Cancer 2022
- Lucence Announces Publication of Validation Study for LiquidHALLMARK ctDNA Liquid Biopsy Assay
- Ultivue Announces AI Partner Ecosystem to Accelerate Analysis of Multiplex Immunofluorescence Image Data in Translational Medicine
- BC Platforms, Euformatics and Oncompass Medicine form a partnership to develop oncology NGS workflows for buyer consortium of seven major European hospitals
- Delfi Diagnostics Enters into Broad Research Agreement with Top U.S. Cancer Center
- AHN Partners With Illumina to Assess Role of Comprehensive Genomic Profiling
- Avalon GloboCare Signs MOU to Form Strategic Partnership with Lu Daopei Hematology Institute to Develop Precision Companion Diagnostics for Cellular Therapy
Clinical trials and drug development (14)
- Genentech Reports Interim Results for Phase III SKYSCRAPER-01 Study in PD-L1-High Metastatic Non-Small Cell Lung Cancer
- CG Oncology Presents Additional Phase 2 Data with CG0070 in Combination with KEYTRUDA® (pembrolizumab) in Non-Muscle-Invasive Bladder Cancer Unresponsive to Bacillus Calmette-Guerin
- Bristol Myers Squibb Provides Update on CheckMate -901 Trial Evaluating Opdivo (nivolumab) Plus Yervoy (ipilimumab) as First-Line Treatment for Patients with Unresectable or Metastatic Urothelial Carcinoma
- Sugemalimab Demonstrates Clinically Meaningful PFS Boost in Unresectable NSCLC
- Copanlisib Shows Clinical Activity in PIK3CA-Mutated Tumors
- Tucatinib Plus Trastuzumab Yields Positive Results in Patients with HER2-Positive mCRC
- Oritinib Shows Promise in EGFR T790M+ NSCLC
- Combining Camrelizumab and Chemotherapy Improves Overall Survival in Squamous NSCLC
- First-line Niraparib Improves PFS in Ovarian Cancer
- DCP-001 Yields MRD Responses Leading to Boosts in Survival in Patients With AML
- Odronextamab Elicits Robust, Durable Responses in Relapsed/ Refractory B-Cell NHL
- Endocrine Therapy Plus Bevacizumab Shows Benefit in ER+/HER2- Breast Cancer
- Oleclumab/Monalizumab With Durvalumab Improves Response and PFS Over Monotherapy in NSCLC
- T-DXd Plus Nivolumab Shows Promise for Patients With HER2-Expressing Urothelial Carcinoma
Observational studies (1)
Merge and acquisitions (1)
- Proteros Expands Oncology Collaboration and License Agreement with AstraZeneca
- Mainz Biomed & Dante Labs Announce Partnership for the Commercialization of ColoAlert in Europe and the United Arab Emirates (UAE)
- Aadi Bioscience Announces Collaborations with Next Generation Sequencing Leaders