Bob Li
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Lexology,
Cancer Discovery
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Articles by Bob Li
Germline homologous recombination deficiency influences TP53 -mutant clonal hematopoiesis fitness during platinum and PARP inhibitor treatment
Abstract Poly(ADP-ribose) polymerase inhibitors (PARPi) are commonly used in tumors with homologous recombination deficiency (HRD) but are associated with an increased risk of therapy-related myeloid neoplasms (tMN). Clonal hematopoiesis (CH) driven by DNA damage response (DDR) mutations is the origin of most tMN. Here, to better understand the causes of tMN following PARPi therapy, we studied the relationship between PARPi use and CH.
PTCH1 mutations and tumor-agnostic clinical outcomes with hedgehog pathway inhibitors across cancer types
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Abstract Loss-of-function (LOF) alterations in PTCH1 are a hallmark of basal cell carcinoma (BCC) and drive activation of the Hedgehog (Hh) signaling pathway. Hh inhibitors are approved to treat advanced BCC, but little is known about the frequency, biology, and treatment of PTCH1 alterations in other cancers. We analyzed PTCH1 LOF alterations across diverse solid tumors and evaluated outcomes of patients with non-BCC tumors who received Hh inhibitors.
By Antoine Désilets, Matteo Repetto, Monica Chen Verified, Bryan Novak, Emiliano Cocco, Yelena Kemel, Pier Selenica, Allison Richards, Mark T. A. Donoghue, Dazhi Liu, Ezra Y Rosen, Aliya Khurram, Britta Weigelt, Bob Li, Rona Yaeger, Marc Ladanyi, Chaitanya Bandlamudi, Ying Liu, Maria I. Carlo, Lauren G. Banaszak, Zsofia K. Stadler, Kenneth Offit, Diana Mandelker, Alan Ho, Alexander Drilon, Yonina R. Murciano-Goroff, Soo Ryum Yang, Cristal Velilla, Alicia Latham
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Nature
Verified
China issues new countering improper extraterritorial jurisdiction regulations
On April 7, 2026, the State Council of the People's Republic of China issued the Regulations on Countering Improper Extraterritorial Jurisdiction by Foreign States (the "Regulations"), which entered into force on the same date. 1 The Regulations establish a formalized legal framework for identifying and responding to foreign laws, regulations, and enforcement actions that PRC authorities identify as "improper exercises of extraterritorial jurisdiction".
China issues new supply chain security regulations
On March 31, 2026, the State Council of the PRC issued the Provisions on Industrial and Supply Chain Security (State Council Order No. 834) (the "Provisions"), which entered into force on the same date.1 The Provisions establish a national framework for safeguarding the security and stability of China's industrial and supply chains.
AI Watch: Global regulatory tracker - China | JD Supra
The Interim AI Measures is China's first specific, administrative regulation on the management of generative AI services.
AI Watch: Global regulatory tracker - China | JD Supra
The Interim AI Measures is China's first specific, administrative regulation on the management of generative AI services.
DNA liquid biopsy-based prediction of cancer-associated venous thromboembolism - Nature Medicine
Abstract Cancer-associated venous thromboembolism (VTE) is a major source of oncologic cost, morbidity and mortality. Identifying high-risk patients for prophylactic anticoagulation is challenging and adds to clinician burden. Circulating tumor DNA (ctDNA) sequencing assays (‘liquid biopsies’) are widely implemented, but their utility for VTE prognostication is unknown.
AI Watch: Global regulatory tracker - China | JD Supra
The Interim AI Measures is China's first specific, administrative regulation on the management of generative AI services.
Trastuzumab deruxtecan in patients with solid tumours harbouring specific activating HER2 mutations (DESTINY-PanTumor01): an international, phase 2 study
1. Najjar MK Manore SG Regua AT Lo H-W Antibody-drug conjugates for the treatment of HER2-positive breast cancer. Genes. 2022; 132065 2. Essadi I Benbrahim Z Kaakoua M Reverdy T Corbaux P Freyer G HER2-positive metastatic breast cancer: available treatments and current developments. Cancers. 2023; 151738 3. Abrahão-Machado LF Jácome AA Wohnrath DR et al. HER2 in gastric cancer: comparative analysis of three different antibodies using whole-tissue sections and tissue microarrays. World J Gastroenterol.
Targeting KRAS in cancer - Nature Medicine
Abstract RAS family variants—most of which involve KRAS—are the most commonly occurring hotspot mutations in human cancers and are associated with a poor prognosis. For almost four decades, KRAS has been considered undruggable, in part due to its structure, which lacks small-molecule binding sites. But recent developments in bioengineering, organic chemistry and related fields have provided the infrastructure to make direct KRAS targeting possible.
China Released New Regulations to Ease Requirements for Outbound Cross-Border Data Transfers | JD Supra
April 2, 2024 Xue Feng, Bingna Guo, Bob Li White & Case LLP + Follow x Following x Following - Unfollow Contact To embed, copy and paste the code into your website or blog: On March 22, 2024, the Cyberspace Administration of China (the "CAC") issued the highly anticipated final Regulations on Promoting and Regulating Cross-Border Data Flows (the "Regulations on Cross-Border Data Flows"), effective immediately.
China Released New Regulations to Ease Requirements for Outbound Cross-Border Data Transfers
On March 22, 2024, the Cyberspace Administration of China (the "CAC") issued the highly anticipated final Regulations on Promoting and Regulating Cross-Border Data Flows (the "Regulations on Cross-Border Data Flows"), effective immediately. The CAC issued a Q&A along with the new regulations that addresses and clarifies certain questions.
Genomic analysis and clinical correlations of non-small cell lung cancer brain metastasis - Nature Communications
Abstract Up to 50% of patients with non-small cell lung cancer (NSCLC) develop brain metastasis (BM), yet the study of BM genomics has been limited by tissue access, incomplete clinical data, and a lack of comparison with paired extracranial specimens. Here we report a cohort of 233 patients with resected and sequenced (MSK-IMPACT) NSCLC BM and comprehensive clinical data.
The Law on Foreign Relations of the People’s Republic of China became effective on 1 July 2023 | JD Supra
The Law on Foreign Relations of the PRC (中华人民共和国对外关系法) (the "Foreign Relations Law") became effective on 1 July 2023. In summary, the Foreign Relations Law provides, for the first time, a comprehensive framework for China's foreign relations. The stated aim of the law is to "safeguard China's national sovereignty, national security and development interests and uphold international fairness and justice".
China’s Standard Contract for the Outbound Cross-border Transfer of Personal Information is in Effect | JD Supra
July 7, 2023 Xue Feng, Bingna Guo, Bob Li White & Case LLP + Follow x Following x Following - Unfollow Contact To embed, copy and paste the code into your website or blog: China's Cybersecurity Law ("CSL"), Personal Information Protection Law ("PIPL") and Data Security Law ("DSL") set a series of rules and requirements for the cross-border transfer of personal information located in China.
China’s Standard Contract for the Outbound Cross-border Transfer of Personal Information is in Effect
China's Cybersecurity Law ("CSL"), Personal Information Protection Law ("PIPL") and Data Security Law ("DSL") set a series of rules and requirements for the cross-border transfer of personal information located in China. These rules and requirements have strong impacts on the business activities of companies operating in or investing in China.
China Releases Draft Amendments to The Anti-Unfair Competition Law | JD Supra
January 30, 2023 Mark Chu, Bingna Guo, Bob Li White & Case LLP + Follow x Following x Following - Unfollow Contact To embed, copy and paste the code into your website or blog: On 22 November 2022, China's State Administration for Market Regulation ("SAMR") released the Draft Amendments to the Anti-Unfair Competition Law ("Draft AUCL Amendments").
China Releases Draft Amendments to The Anti-Unfair Competition Law
On 22 November 2022, China's State Administration for Market Regulation ("SAMR") released the Draft Amendments to the Anti-Unfair Competition Law ("Draft AUCL Amendments").
We Need a Global System for Testing and Approving Cancer Treatments
By globally harmonizing regulations for the approval of oncology therapies subject to clinical trials, it would be possible to reduce the number of global cancer-related deaths per year by 10% to 20%, or 1 million to 2 million lives. That’s because the lack of such an international system is slowing the approval of treatments around the world, according to research that we conducted.
China Issues Guidance on the Security Assessment of Outbound Data Transfers | JD Supra
October 10, 2022 Bingna Guo, Bob Li, May Xiao White & Case LLP + Follow x Following x Following - Unfollow Contact To embed, copy and paste the code into your website or blog: The Cybersecurity Law ("CSL"),1 Personal Information Protection Law ("PIPL"),2 and Data Security Law ("DSL")3 of the People's Republic of China (the "PRC") introduced a security assessment of the outbound transfer of important data and personal information.
FDA grants Enhertu accelerated approval for HER2-mutated non-small cell lung cancer
Source/Disclosures Disclosures: Li reports uncompensated advisory services provided to Daiichi Sankyo and AstraZeneca. We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. The FDA granted accelerated approval to fam-trastuzumab deruxtecan-nxki for treatment of adults with HER2-mutated unresectable or metastatic non-small cell lung cancer.
Reimagining patient-centric cancer clinical trials: a multi-stakeholder international coalition - Nature Medicine
The Bloomberg New Economy International Cancer Coalition brings together academia, industry, government, patient advocacy and policy think tanks to leverage technology and collaboration to improve patient access to clinical trials and to harmonize regulations aiming to accelerate cancer cures and prevention worldwide in the post-pandemic era. The COVID-19 pandemic upended the infrastructure and delivery of oncology clinical trials worldwide.
Highlights • Drug-related interstitial lung disease (ILD)/pneumonitis diagnosis is challenging. • Careful monitoring, prompt diagnosis, and appropriate management are important. • Most events are low grade and can be managed safely. • Education is critical to ensure potential ILD/pneumonitis is proactively identified. • We suggest using a multidisciplinary approach. Abstract Trastuzumab deruxtecan (T-DXd; DS-8201) is an antibody-drug conjugate targeting human epidermal growth factor receptor 2.
China Issued New Measures for Cybersecurity Review in 2022 | JD Supra
The Cyberspace Administration of China (the "CAC"), in conjunction with 12 other government departments (collectively, the "Working Mechanism"), issued the New Measures for Cybersecurity Review (the "New Measures") on January 4, 2022. The New Measures amends the Measures for Cybersecurity Review (Draft Revision for Comments) (the "Draft Measures") released on July 10, 2021 and will come into effect on February 15, 2022.
The Cyberspace Administration of China (the "CAC"), in conjunction with 12 other government departments (collectively, the "Working Mechanism"), issued the New Measures for Cybersecurity Review (the "New Measures") on January 4, 2022. The New Measures amends the Measures for Cybersecurity Review (Draft Revision for Comments) (the "Draft Measures") released on July 10, 2021 and will come into effect on February 15, 2022.
OFAC sanctions compliance guidance for the virtual currency industry
On October 15, 2021, the US Department of the Treasury’s Office of Foreign Assets Control ("OFAC") issued a brochure to promote sanctions compliance in the virtual currency industry (the "Guidance")1 and updated two related Frequently Asked Questions (FAQs 5592 and 646). The growing prevalence of virtual currency in the global economy denotes greater exposure to sanctions risks.
Clinical Validation of Guardant360 CDx as a Blood-Based Companion Diagnostic for Sotorasib
Highlights • Insufficient genotyping remains common in non–small-cell lung cancer (NSCLC) • Comprehensive genotyping is critical for proper management of NSCLC patients. • Guardant360 CDx is a next-generation sequencing-based liquid biopsy test. • Guardant360 CDx has clinical validity in identifying KRAS p.G12C-mutant NSCLC. • Guardant 360 may be a useful tool for determining eligibility of sotorasib therapy.
China Personal Information Protection Law Will Become Effective Soon | JD Supra
On August 20, 2021, the Standing Committee of the National People's Congress of the People's Republic of China ("PRC") passed the Personal Information Protection Law ("PIPL"), which will come into effect on November 1, 2021. The PIPL will work together with the Cybersecurity Law ("CSL") and the Data Security Law ("DSL") to establish a broader regulatory architecture governing cybersecurity and data privacy protection in China.
Trastuzumab deruxtecan induces durable responses in HER2-mutated NSCLC
September 18, 2021 2 min read Save Perspective from Source/Disclosures Published by: Source: Li BT, et al. Abstract LBA46. Presented at: European Society for Medical Oncology Congress (virtual meeting); Sept. 17-21, 2021. Disclosures: AstraZeneca and Daiichi Sankyo funded this study.
Trastuzumab Deruxtecan in HER2-Mutant Non–Small-Cell Lung Cancer | NEJM
Supported by Daiichi Sankyo and AstraZeneca. Dr. Li was also supported by grants from the National Institutes of Health (P30 CA008748 and 1R01CA249666-01A1) to the Memorial Sloan Kettering Cancer Center. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org. Drs. Li and Smit contributed equally to this article. This article was published on September 18, 2021, at NEJM.org.
Sotorasib for Lung Cancers with KRAS p.G12C Mutation
37 References 51 Citing Articles Related Articles Abstract Background Sotorasib showed anticancer activity in patients with KRAS p.G12C–mutated advanced solid tumors in a phase 1 study, and particularly promising anticancer activity was observed in a subgroup of patients with non–small-cell lung cancer (NSCLC). Methods Download a PDF of the Research Summary.
How Int’l Collaboration Is Helping To Win A War Greater Than The COVID-19 Pandemic
(Note: This post will appear in the Sept.-Oct. issue of Forbes China. Click here for more information about the 2020 Forbes China Healthcare Summit) By Bob T. Li, MD and Sir Murray F. Brennan, MD The COVID-19 pandemic has created the biggest public health crisis in a century, surpassing 20 million cases and 730,000 deaths worldwide by early August of 2020.1 Against this pandemic backdrop, there is a greater war against an enemy of humanity that is more relentless and lethal.
HER2-Mediated Internalization of Cytotoxic Agents in ERBB2 Amplified or Mutant Lung Cancers
Research Articles Bob T. Li, Flavia Michelini, Sandra Misale, Emiliano Cocco, Laura Baldino, Yanyan Cai, Sophie Shifman, Hai-Yan Tu, Mackenzie L. Myers, Chongrui Xu, Marissa Mattar, Inna Khodos, Megan Little, Besnik Qeriqi, Gregory Weitsman, Clare J. Wilhem, Alshad S. Lalani, Irmina Diala, Rachel A. Freedman, Nancy U. Lin, David B. Solit, Michael F. Berger, Paul R. Barber, Tony Ng, Michael Offin, James M. Isbell, David R. Jones, Helena A.
HER2-Mediated Internalization of Cytotoxic Agents in ERBB2 Amplified or Mutant Lung Cancers
Research Articles Bob T. Li, Flavia Michelini, Sandra Misale, Emiliano Cocco, Laura Baldino, Yanyan Cai, Sophie Shifman, Hai-Yan Tu, Mackenzie L. Myers, Chongrui Xu, Marissa Mattar, Inna Khodos, Megan Little, Besnik Qeriqi, Gregory Weitsman, Clare J. Wilhem, Alshad S. Lalani, Irmina Diala, Rachel A. Freedman, Nancy U. Lin, David B. Solit, Michael F. Berger, Paul R. Barber, Tony Ng, Michael Offin, James M. Isbell, David R. Jones, Helena A.
Targeted therapy shows promise for HER2-mutant NSCLC, other solid tumors
The novel HER2-targeted antibody-drug conjugate fam-trastuzumab deruxtecan-nxki appeared active in a cohort of patients with various heavily pretreated HER2-expressing or HER2-mutant solid tumors, according to results of a dose-expansion study published in Cancer Discovery. The agent demonstrated particularly promising antitumor activity among patients with HER2-mutant non-small cell lung cancer.
Alterations in PTEN and ESR1 promote clinical resistance to alpelisib plus aromatase inhibitors
Abstract Alpelisib is a selective inhibitor of phosphoinositide 3-kinase (PI3K)α, shown to improve outcomes for PIK3CA-mutant, hormone receptor–positive metastatic breast cancers when combined with antiestrogen therapy. To uncover mechanisms of resistance, we conducted a detailed, longitudinal analysis of tumor and plasma circulating tumor DNA (ctDNA) among such patients from a phase I/II trial combining alpelisib with an aromatase inhibitor (NCT01870505).
HER2-mediated internalization of cytotoxic agents in ERBB2 amplified or mutant lung cancers
Research Articles Bob T. Li, Flavia Michelini, Sandra Misale, Emiliano Cocco, Laura Baldino, Yanyan Cai, Sophie Shifman, Hai-Yan Tu, Mackenzie L Myers, Chongrui Xu, Marissa Mattar, Inna Khodos, Megan Little, Besnik Qeriqi, Gregory Weitsman, Clare J. Wilhelm, Alshad S. Lalani, Irmina Diala, Rachel A. Freedman, Nancy U Lin, David B. Solit, Michael F. Berger, Paul R Barber, Tony Ng, Michael Offin, James M Isbell, David R.
How Plaintiffs Can Avoid Hague Service Requirement When Serving Non-U.S. Defendants
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How Plaintiffs Can Avoid Hague Service Requirement When Serving Non-U.S. Defendants | Lexology
In Short The Situation: The Hague Service Convention places time-consuming and complex requirements on a U.S. lawsuit's plaintiff's ability to effect service on non-U.S. defendants. The Result: Recent U.S. court cases highlight key exceptions to the Hague Service Convention that can substantially ease the plaintiff's burden with respect to non-U.S. defendants.
High-intensity sequencing reveals the sources of plasma circulating cell-free DNA variants
Abstract Accurate identification of tumor-derived somatic variants in plasma circulating cell-free DNA (cfDNA) requires understanding of the various biological compartments contributing to the cfDNA pool.
Expanding Treatment in The Neoadjuvant Setting
Neoadjuvant chemotherapy is the standard treatment for patients with stage III lung cancer, but new studies show promise for the combination of neoadjuvant immunotherapy in these patients, before surgery.
The Value of Collecting Population-Based Cancer Stage Data to Support Decision-Making at Organizational, Regional and Population Levels
Healthcare Quarterly, 16(3) July 2013: 27-33.doi:10.12927/hcq.2013.23497 Quality Improvement The Value of Collecting Population-Based Cancer Stage Data to Support Decision-Making at Organizational, Regional and Population Levels James D. Brierley, John R. Srigley, Marta Yurcan, Bob Li, Rami Rahal, Jillian Ross, Mary Jane King, Michael Sherar, Rick Skinner and Carol Sawka Tweet Abstract The stage of a patient's cancer at diagnosis is essential to predict the prognosis and plan the treatment.
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