- |||||||||| Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen
ACUTE CARDIOMYOPATHY AFTER INITIATION OF CABOZANTINIB, A MULTITYROSINE KINASE INHIBITOR (Poster Hall_Hall F) - Jan 4, 2023 - Abstract #ACCWCC2023ACC_WCC_1041; Our case demonstrates acute cardiomyopathy as a potential cardiovascular toxicity of cabozantinib in a patient with low risk of cardiovascular disease. With the expanding U.S. Food and Drug Administration approvals for cabozantinib, ongoing vigilance for associated cardiomyopathy is needed with close surveillance and timely treatment.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
UNCHECKED VT (Poster Hall_Hall F) - Jan 4, 2023 - Abstract #ACCWCC2023ACC_WCC_725; Though uncommon, checkpoint inhibitors may lead to the development of cardiotoxic adverse events through immune-mediated effects on myocardium, pericardium, and conduction system.Case: 71-year-old-female with hypertension, hyperlipidemia, systolic heart failure, and end-stage renal disease presented with symptomatic monomorphic ventricular tachycardia requiring three cardioversions and amiodarone... With increasing use of ICI in the treatment of malignancy, clinicians should be aware of potential adverse cardiovascular events, including development of cardiomyopathy and arrhythmia.
- |||||||||| Opdivo (nivolumab) / BMS, Aliqopa (copanlisib) / Bayer, Yervoy (ipilimumab) / BMS
Biomarker, Trial completion date, Trial primary completion date, Checkpoint inhibition, IO biomarker: Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Immunotherapy (Nivolumab With or Without Ipilimumab) in Patients With Advanced Solid Cancers That Have Changes in the Following Genes: PIK3CA and PTEN (clinicaltrials.gov) - Jan 4, 2023 P1/2, N=102, Recruiting, While limited evidence for the management of this condition exists, early permanent pacing should be considered. Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Dec 2023
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
Timing of Adjuvant Immunotherapy in Stage III Melanoma, Does it Matter? (Veterans Memorial Auditorium) - Jan 3, 2023 - Abstract #SSO2023SSO_221; Additional work is needed to better understand the underlying mechanisms and implications of timing of adjuvant ICI on long-term outcomes. Learning Objectives: Upon completion, participant will be able to describe indications for adjuvant therapy in melanoma Upon completion, participant will be able to describe implications of adjuvant therapy on outcomes in melanoma Upon completion, participant will be able to describe implications of timing of adjuvant therapy in melanoma
- |||||||||| Actemra IV (tocilizumab) / Roche, JW Pharma, Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
P2 data, Journal: Phase 2 study of ipilimumab, nivolumab, and tocilizumab combined with stereotactic body radiotherapy in patients with refractory pancreatic cancer (TRIPLE-R). (Pubmed Central) - Jan 3, 2023 P2 Pepi has the potential to augment the activity of CI in melanoma without additional toxicity. The combination of ipilimumab, nivolumab, tocilizumab, and SBRT in patients with PC did not meet the prespecified criteria for expansion for full accrual.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
Journal, Adverse events, Checkpoint inhibition: Immune checkpoint inhibitors induced pituitary immune-related adverse events: diagnosis and management (Pubmed Central) - Dec 29, 2022 In October 2021, the first CTLA-4 inhibitor, ipilimumab, which has a different spectrum of irAEs was also approved by NMPA...In this review of latest literature, we have summarized the incidence, possible mechanisms, time of onset, clinical presentations, hormone test, pituitary imaging, treatment strategies and recovery patterns of pituitary irAEs. By referring to domestic and foreign clinical guidelines, we have proposed practical suggestions for screening, diagnosing and treating pituitary irAEs.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
Review, Journal, MSi-H Biomarker, PD(L)-1 Biomarker, IO biomarker, Surgery: Pathologic complete response after laparoscopic surgery following treatment with nivolumab and ipilimumab for anticancer drug-resistant MSI-high descending colon cancer: a case report and literature review. (Pubmed Central) - Dec 28, 2022 Herein, we report a case of anticancer drug-resistant MSI-high colon cancer that was resected after treatment with immune checkpoint inhibitors, and a pCR was achieved. This new treatment strategy can be used for the treatment of cases that are not responsive to conventional therapies.
- |||||||||| Yervoy (ipilimumab) / Ono Pharma, BMS
Review, Journal, Checkpoint inhibition, Metastases: Immunotherapy for Melanoma: The Significance of Immune Checkpoint Inhibitors for the Treatment of Advanced Melanoma. (Pubmed Central) - Dec 24, 2022 Since 2014, anti-programmed cell death 1 (PD1) antibodies have been recognized as anchor drugs for treating advanced melanoma, with or without additional combination drugs such as ipilimumab, but the efficacies of these immunotherapies are not fully satisfactory. In this review, we describe the development of the currently available anti-PD1 Abs-based immunotherapies for advanced melanoma, focusing on their efficacy and immune-related adverse events (AEs), as well as clinical trials still ongoing for the future treatment of advanced melanoma.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
MODULE 5: The Changing Management Paradigm for Localized CRC (San Francisco Marriott Marquis, Golden Gate Ballroom, Salon A (B2 Level)) - Dec 23, 2022 - Abstract #ASCOGI2023ASCO_GI_1000; This activity is supported by educational grants from Bayer HealthCare Pharmaceuticals, Exelixis Inc, Lilly, Natera Inc, and Seagen Inc. Benefits and limitations of current approaches for surveillance and treatment decision-making for patients with localized CRC who have undergone curative-intent therapy Mechanistic rationale for and available data (eg, from the CIRCULATE-Japan study) with the use of circulating tumor DNA (ctDNA)/minimal residual disease (MRD) monitoring in the management of localized CRC Circulating tumor DNA (ctDNA)/minimal residual disease (MRD) monitoring in the management of localized CRC: Mechanistic rationale and available data (eg, from the CIRCULATE-Japan study) Studies (eg, CIRCULATE-US, BESPOKE CRC) examining the utility of ctDNA/MRD testing in treatment decision-making and monitoring for recurrence; potential clinical impact Biologic rationale for the use of immune checkpoint inhibitors for patients with localized CRC Available findings from the Phase II NICHE and NICHE-2 trials investigating the efficacy and safety of nivolumab/ipilimumab as neoadjuvant therapy for patients with nonmetastatic CRC Ongoing Phase III trials evaluating the role of immune checkpoint inhibitors for localized CRC
- |||||||||| MODULE 2: Optimizing the Use of Immune Checkpoint Inhibitors in the Management of mCRC (San Francisco Marriott Marquis, Golden Gate Ballroom, Salon A (B2 Level)) - Dec 23, 2022 - Abstract #ASCOGI2023ASCO_GI_997;
This activity is supported by educational grants from Bayer HealthCare Pharmaceuticals, Exelixis Inc, Lilly, Natera Inc, and Seagen Inc. Key data informing the rational incorporation of pembrolizumab, nivolumab and nivolumab/ipilimumab for microsatellite instability-high/mismatch repair-deficient mCRC Early results with and ongoing investigation of immune checkpoint inhibitors in combination with other systemic approaches (eg, chemotherapy, targeted therapy) for MSI-H/dMMR advanced CRC Biologic rationale for the investigation of immune checkpoint inhibition for microsatellite-stable (MSS) mCRC Clinical activity and safety observed with cabozantinib in combination with anti-PD-1/PD-L1 antibodies among patients with MSS mCRC in early-phase trials (eg, COSMIC-021 cohort 16, CAMILLA cohort 2) Pharmacologic and pharmacodynamic comparison of cabozantinib and XL092 Design, eligibility and efficacy and safety endpoints for the Phase III STELLAR-303 trial comparing XL092/atezolizumab to regorafenib for relapsed/refractory (R/R) MSS mCRC Available data with and ongoing investigation of other immune checkpoint inhibitor-based strategies (eg, lenvatinib/pembrolizumab, regorafenib/pembrolizumab) for MSS mCRC Available data with and ongoing investigation of other immune checkpoint inhibitor-based strategies (eg, lenvatinib/pembrolizumab, regorafenib/pembrolizumab) for patients with MSS mCRC
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
MODULE 4: Current Approaches to the Management of Esophageal Cancer (San Francisco Marriott Marquis, Golden Gate Ballroom, Salon A (B2 Level)) - Dec 23, 2022 - Abstract #ASCOGI2023ASCO_GI_957; CME Provider and Supporter(s): This event is organized and accredited by Research to Practice and supported through educational grants provided by Astellas, AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb Company, Daiichi Sankyo Inc, and Lilly. Design, eligibility criteria and primary and secondary endpoints of the Phase III CheckMate 577 study evaluating nivolumab as adjuvant therapy for patients with resected esophageal or GEJ cancer Available efficacy and safety outcomes from the CheckMate 577 trial; FDA approval of and patient selection for adjuvant nivolumab Published data from the Phase III CheckMate 648 study of nivolumab/chemotherapy and nivolumab/ipilimumab versus chemotherapy alone for advanced squamous cell carcinoma of the esophagus; recent FDA approval of these regimens Major findings from the Phase III KEYNOTE-590 study evaluating first-line pembrolizumab combined with chemotherapy versus chemotherapy alone for advanced esophageal cancer; current role in clinical practice Other promising immune checkpoint inhibitor-based strategies for localized or advanced esophageal cancer
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
MODULE 1: Optimizing the Selection of Therapy for Newly Diagnosed Advanced Gastric or Gastroesophageal Junction (GEJ) Cancer (San Francisco Marriott Marquis, Golden Gate Ballroom, Salon A (B2 Level)) - Dec 23, 2022 - Abstract #ASCOGI2023ASCO_GI_954; CME Provider and Supporter(s): This event is organized and accredited by Research to Practice and supported through educational grants provided by Astellas, AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb Company, Daiichi Sankyo Inc, and Lilly. Design, eligibility criteria and key efficacy and safety endpoints evaluated in the Phase III CheckMate 649 study comparing first-line nivolumab/chemotherapy or nivolumab/ipilimumab to chemotherapy alone for advanced gastroesophageal adenocarcinoma Major efficacy and safety findings reported from the CheckMate 649 trial; impact of PD-L1 expression on outcomes FDA-approved indication for nivolumab in combination with chemotherapy as first-line treatment and optimal incorporation into current management algorithms Emerging findings from the Phase III KEYNOTE-859 study demonstrating a statistically significant improvement in overall survival with first-line pembrolizumab and chemotherapy compared to chemotherapy alone for advanced gastric/GEJ adenocarcinoma Frequency of microsatellite instability-high (MSI-H) gastroesophageal adenocarcinoma; implications for current clinical care Published findings from the Phase II NEONIPIGA trial evaluating nivolumab/ipilimumab as neoadjuvant therapy for resectable locally advanced microsatellite instability-high gastric adenocarcinoma
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
Journal, Metastases: Can we do without chemotherapy? A perspective on the combinations nivolumab-chemotherapy and nivolumab-ipilimumab in metastatic gastric and esophageal cancer. (Pubmed Central) - Dec 23, 2022 Design, eligibility criteria and key efficacy and safety endpoints evaluated in the Phase III CheckMate 649 study comparing first-line nivolumab/chemotherapy or nivolumab/ipilimumab to chemotherapy alone for advanced gastroesophageal adenocarcinoma Major efficacy and safety findings reported from the CheckMate 649 trial; impact of PD-L1 expression on outcomes FDA-approved indication for nivolumab in combination with chemotherapy as first-line treatment and optimal incorporation into current management algorithms Emerging findings from the Phase III KEYNOTE-859 study demonstrating a statistically significant improvement in overall survival with first-line pembrolizumab and chemotherapy compared to chemotherapy alone for advanced gastric/GEJ adenocarcinoma Frequency of microsatellite instability-high (MSI-H) gastroesophageal adenocarcinoma; implications for current clinical care Published findings from the Phase II NEONIPIGA trial evaluating nivolumab/ipilimumab as neoadjuvant therapy for resectable locally advanced microsatellite instability-high gastric adenocarcinoma No abstract available
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Sutent (sunitinib) / Pfizer, Yervoy (ipilimumab) / Ono Pharma, BMS
Journal, PD(L)-1 Biomarker, IO biomarker, Metastases: Long-term outcomes with nivolumab plus ipilimumab versus sunitinib in first-line treatment of patients with advanced sarcomatoid renal cell carcinoma. (Pubmed Central) - Dec 23, 2022 P3 No abstract available Among patients with intermediate/poor-risk sRCC, NIVO+IPI maintained long-term survival benefits and demonstrated durable and deep responses over SUN at minimum follow-up of 5 years, supporting NIVO+IPI as a preferred first-line therapy in this population.
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