News Highlights – April 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)
- Yescarta® Receives U.S. FDA Approval as First CAR T-cell Therapy for Initial Treatment of Relapsed or Refractory Large B-cell Lymphoma (LBCL)
- Accutar Biotechnology Receives NMPA Clearance of IND Application for AC0682 in ER-Positive Breast Cancer
- European Commission Approves Immunocore's T-Cell Receptor Therapy Kimmtrak in Uveal Melanoma Bristol Myers Squibb Receives European
- Commission Approval for Opdivo (nivolumab) as Adjuvant Treatment for Patients with Radically Resected, High-Risk Muscle-Invasive Urothelial Carcinoma with Tumor Cell PD-L1 Expression ≥1%
- Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) Plus Yervoy (ipilimumab) as First-Line Treatment for Patients with Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma with Tumor Cell PD-L1 Expression ≥ 1%
- Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) with Chemotherapy as First-Line Treatment for Patients with Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma with Tumor Cell PD-L1 Expression ≥ 1%
- Bristol Myers Squibb Receives European Commission Approval for CAR T Cell Therapy Breyanzi (lisocabtagene maraleucel) for Certain Forms of Relapsed or Refractory Large B-cell Lymphoma
- BeiGene Announces European Medicines Agency Acceptance of Marketing Authorization Applications for Tislelizumab for the Treatment of Patients with ESCC and NSCLC
- European Commission Approves PADCEV™ (enfortumab vedotin) for Locally Advanced or Metastatic Urothelial Cancer
- ENHERTU® (fam-trastuzumab deruxtecan-nxki) granted Priority Review in the US for patients with previously treated HER2-mutant metastatic non-small cell lung cancer
- Incyte Announces Positive CHMP Opinion for Capmatinib (Tabrecta®) for the Treatment of METex14 Advanced Non-Small Cell Lung Cancer
- CHMP recommends EU approval of Roche’s Tecentriq as adjuvant treatment for a subset of people with early-stage non-small cell lung cancer
- Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) Plus Chemotherapy as Neoadjuvant Treatment, Then Continued as Adjuvant Monotherapy After Surgery for Locally Advanced, or High-Risk Early-Stage Triple-Negative Breast Cancer (TNBC)
- Tremelimumab accepted under Priority Review in the US for patients with unresectable liver cancer in combination with Imfinzi
- FDA Grants Fast Track Designation to ONC-392 for mNSCLC
- FDA Grants FTD to Ofra-Vec Plus Paclitaxel for Platinum-Resistant Ovarian Cancer
- FDA Approval Application for U2 Regimen in CLL and SLL Voluntarily Withdrawn
- ENHERTU® Granted Breakthrough Therapy Designation in U.S. for Patients with HER2 Low Metastatic Breast Cancer
- European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy, With or Without Bevacizumab, for Patients With Persistent, Recurrent or Metastatic Cervical Cancer Whose Tumors Express PD-L1 (CPS ≥1)
- European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) for Patients With Microsatellite Instability-High (MSI-H) or Deficient Mismatch Repair (dMMR) Tumors in Five Different Types of Cancer
- EMA's CHMP Recommends Novartis' Tabrecta for Previously Treated NSCLC With METex14 Skipping Mutation
Dx approvals, market access and reimbursement (8)
- Agilent Companion Diagnostic Expands CE-IVD Mark for PD-L1 IHC 28-8 pharmDx to Include Esophageal Squamous Cell Carcinoma
- Agilent Companion Diagnostic Expands CE-IVD Mark for PD-L1 IHC 28-8 pharmDx to Include Muscle-Invasive Urothelial Carcinoma (MIUC)
- Paige Earns CE-IVD and UKCA Marks for Clinical AI Application to Detect Breast Cancer Metastases in Lymph Nodes
- China NMPA Approves Tislelizumab for Patients with Second-Line Esophageal Squamous Cell Carcinoma
- Genetron Health Nabs CE Mark for Blood Cancer Residual Disease Test Kit
- Lunit Gets CE Mark for AI-Based PD-L1 Expression Test
- NeoGenomics, Eli Lilly to Offer Molecular Testing to Non-Small Cell Lung Cancer Patients
- Texas Oncology Announces Collaboration to Provide More Cancer Patients with Access to Liquid Biopsy Testing from Foundation Medicine
Latest diagnostic developments, investment and CDx deals (7)
- Lucid Diagnostics Provides Updates on Newly Published Esophageal Precancer Clinical Guideline and Proposed Medicare Local Coverage Determination
- Stilla and Promega Announce Co-Marketing Agreement to Offer Complete Digital PCR Workflow Solution
- AmoyDx Signs Strategic Cooperation Agreement with HUTCHMED in China
- Beckman Coulter Life Sciences and Amoy Diagnostics Sign Application Development Agreement for the Biomek Ngenius Next Generation Library Prep System
- AmoyDx, AstraZeneca Collaborate to Develop, Commercialize Companion Diagnostic Tests
- Illumina, Janssen Biotech Form Strategic Partnership to Develop Precision Medicines
- Ansa Biotechnologies Closes Oversubscribed $68 Million Series A Financing to Power the Next Era of DNA-Enabled Industries
Clinical trials and drug development (14)
- Blueprint Medicines Expands Trials of EGFR Inhibitors in NSCLC
- InventisBio Reported Promising Phase I Study Results of a Novel KRAS G12C Inhibitor D-1553 in Cancer Patients
- Next-Generation AstraZeneca PARP1 Inhibitor Shows Activity in Multiple Cancers at Variety of Doses
- CG Oncology Presents Interim Phase 2 Data with CG0070 in Combination with KEYTRUDA® (pembrolizumab) in Non-Muscle-Invasive Bladder Cancer Unresponsive to Bacillus Calmette-Guerin
- Genmab and AbbVie Announce Topline Results for Epcoritamab (DuoBody®-CD3xCD20) From Phase 1/2 Trial in Patients with Relapsed/Refractory Large B-cell Lymphoma (LBCL)
- Sotigalimab/Pembrolizumab Combo Shows Safety and Broad Immune Activity in Metastatic Melanoma
- Novartis Enters KRAS G12C Space With Positive Phase I/II Data in Lung, Colorectal Cancer
- Pembrolizumab Becomes First Anti-PD-1 Therapy to Show Activity in Kaposi’s Sarcoma
- Cyclacel Enrolling Patients in Phase I/II PLK1 Inhibitor Trial
- BeiGene Updates Phase III Data, Biomarker Analysis for Anti-PD-1 Drug in Nasopharyngeal Cancer
- Tislelizumab Holds PFS Benefit After 15 Months in Recurrent/Metastatic Nasopharyngeal Carcinoma
- CG0070 With Pembrolizumab Shows Encouraging Results in BCG-Unresponsive NMIBC
- Alectinib Shows Activity in ALK-Rearranged Advanced Solid Tumors
- Global Phase 3 Trial of BeiGene’s PD-1 Inhibitor, Tislelizumab, in Combination with Chemotherapy Meets Primary Endpoint in First-Line Advanced Esophageal Squamous Cell Carcinoma
Observational studies (5)
Merge and acquisitions (2)