The approval of the MET inhibitor tepotinib for the treatment of advanced lung cancer with MET exon 14 (METex14) skipping mutations was mainly based on the results obtained in Cohort A of the phase II VISION study [3]. The primary end point was the overall response rate. - Abstract #P1.16-01 ; Pres time: August 07, 2022 ;17:00:00 - 19:00:00 ; " Introduction: The CHRYSALIS study (NCT02609776) is an ongoing Phase 1 trial evaluating the combination of amivantamab (ami) and lazertinib (laz) in patients with epidermal growth factor receptor (EGFR)-mutant (EGFRm) NSCLC. At WCLC 2022, Li et al. Read More. The MET-2 cohort of the CHRYSALIS study now provides the first evidence of amivantamab activity in MET-driven NSCLC . The Guardant360 CDx assay was also approved in tandem as a companion diagnostic for the agent in this indication. The predominant side effect was infusion-related reactions, affecting 69%, but just 5% of patients experienced this at grade 3 or higher, and these reactions were very rarely seen after the first day of cycle 1, he emphasized. In the overall population, ORRs were 37% and 41% for the doublet and triplet therapy, respectively. Methods: The primary end points were dose-limiting toxicity and overall response rate. 2022IASLCWCLC2022 869+ WCLC EGFR TKIEGFR WCLC CHRYSALIS-2LACPEGFR TKIORR50%! The assessment included a ctDNA analysis according to which half of patients showed TP53 co-mutations. Shirish M. Gadgeel, MD Nicolas Girard, MD, PhD Format: Microsoft PowerPoint (.ppt) File Size: 1.10 MB Released: February 15, 2021 Acknowledgements Provided by Clinical Care Options, LLC Contact Info Supported by educational grants from Explore all WCLC News Articles. The phase III TROPION-Lung08 trial is evaluating Dato-DXd plus pembrolizumab vs. pembrolizumab alone as first-line therapy in patients with advanced or metastatic NSCLC and PD-L1 TPS >50% (NCT05215340). . The ORRs for these three subgroups were 21%, 36%, and 39%, respectively. Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy in Relapsed/Refractory EGFR-Mutant NSCLC. Raritan, NJ: Janssen; December 3, 2020. Activating EGFR mutations were found in 15 of 18 patients at baseline but were undetectable by day 1 of cycle 3. Median duration of response and median PFS were not estimable. the chrysalis study (nct02609776) is evaluating amivantamab, a fully human bispecific antibody that targets epidermal growth factor receptor (egfr) and mesenchymal epithelial transition factor (met) mutations, zin combination with the third-generation egfr tyrosine kinase inhibitor (tki) lazertinib in patients with non-small cell lung cancer Median duration of response, progression-free survival (PFS) and overall survival (OS) were not estimable at the time of the analysis. Both drugs are designed to treat patients harbouring tumours with EGFR exon 20 insertions mutations. Amivantamab plus chemotherapy is also being compared with chemotherapy alone as a frontline treatment for patients with advanced or metastatic NSCLC harboring EGFR exon 20 insertions in the phase 3 PAPILLON trial (NCT04538664). FDA. nsclc nsclc Treatment-related AEs (TRAEs) led to permanent discontinuation in 14.7%. Ongoing responses were reported for 11 of the 15 patients and 10 patients had responded for 6 months or longer. Amivantamab exhibited a tolerable safety profile consistent with on-target inhibition of EGFR and MET pathways. https://www.kangbixing.com/drug/mobotini/ Amivantamab, a novel, fully human bispecific antibody targeting both the epidermal growth factor receptor (EGFR) and MET, is currently being explored as a monotherapy in non-small cell lung cancer (NSCLC). TEAEs due to Dato-DXd led to discontinuation in 15% and 10%, respectively. Program at a Glance - IASLC 2022 WCLC World Conference on Lung Cancer PROGRAM AT A GLANCE Program at a Glance Industry Sponsored Symposia & Satellite CME Symposia Program Committee Tweets by IASLC Please click here to view the detailed Program: Full Session Information This program is a preliminary version and is subject to change without notice. Amivantamab has demonstrated monotherapy activity (objective response rate of 40%, median duration of response of 11.1 months) in EGFR Exon 20 insertion non-small cell lung cancer (NSCLC) that progressed after platinum-based chemotherapy and was recently approved for this indication in the United States. Lindsay Rosenwald's Fortress Bio 'Uniquely' Positioned to Capitalize on Current Long Biotech Winter. Login to view comments. Ninety-seven percent of grade 3/4 hepatotoxicity events resolved with corticosteroids, treatment modification, and/or discontinuation. Median age of study participants was 70 years with slightly more women (63%). Tepotinib was generally well tolerated, with most AEs being mild to moderate. Like Cohort A, these patients had received tepotinib 500mg/d in the first, second, or third lines after central confirmation of METex14 skipping by liquid and/or tissue biopsy. Oct 31, 2022 08:00am. Keeping you informed. The median progression-free survival (PFS) was 8.3 months (95% CI, 6.5-10.9) and the median overall survival (OS) was 22.8 months (95% CI, 14.6%-NR). These results were identical in patients with baseline brain metastases (n=10). All patients had advanced KRASG12C-mutated NSCLC and had received or refused prior standard therapies. Amivantamab was given at a weekly dose of 1050 mg (bodyweight <80 kg) or 1400 mg (80 kg) for the 4-week cycle and twice weekly thereafter alongside lazertinib 240 mg/day. "Patients with NSCLC harbouring EGFR exon 20 insertion mutations represent a specific population who have been underserved by current treatment options that are limited in both number and efficacy. Videos B. Amivantamab and Lazertinib in Treatment-Nave EGFRm NSCLC. An additional area of exploration could come in the adjuvant setting, Spira concludes. Accessed May 21, 2021. https://bit.ly/2QIun2u, FDA Approves Cemiplimab Plus Chemo in Advanced NSCLC, NVL-520 May Stop Tumor Growth, Garner CNS Response in ROS1+ NSCLC and Solid Tumors, Sinoatrial Node Radiation During CRT May Increase Risk of Atrial Fibrillation in SCLC and NSCLC, 2022 ASCO Genitourinary Cancers Symposium Urothelial Cancer Updates, Contemporary Concepts in Hematologic Oncology, Insights from Experts at Mayo Clinic on Translating Evidence to Clinical Practice, Optimizing Outcomes in Patients with HER2+ Metastatic Breast Cancer, Real-World Evidence in NSCLC Guides Clinical Decisions, Targeting NSCLC with Uncommon EGFR Mutations, Nurse Practitioners/Physician's Assistants. The safety profile of the regimen was consistent with the profiles of the individual agents. Amivantamab is currently awaiting approval in the United States and Europe for use in the treatment of patients with NSCLC and EGFR . Likewise, amivantamab/lazertinib demonstrated clinically significant and durable antitumor activity in the untreated setting. Alexander Spira, MD, PhD, Virginia Cancer Specialists Research Institute, US Oncology Research, Fairfax VA, Dr. Wissam discusses the highlights on adjuvant therapy in cutaneous melanoma, Prof. Nikkels on the TELESPOT project: a Belgian teledermoscopy system in primary healthcare centres for early detection of skin cancer, Prof. Hoeller about the potential role for adjuvant therapy in the treatment of intermediate risk melanoma patients, Podcast with Prof. Cornelis J.A. Most of the events were graded as 1 and 2. Baseline patient demographics indicated a cohort that was majority female (59%), with a median age of 62 years (range, 42-84). Peripheral edema was the most common AE (any grade, 66.5%, grade 3, 10.9%). AmivantamabEGFR- MET EGFRMET amivantamabEGFR ICHRYSALISamivantamabEGFR 20NSCLC WCLCCHRYSALIS OA04.04 amivantamabEGFR 20NSCLCORR36%DOR10 Grade 3 study treatment-related TEAEs occurred in 35% and 54%, respectively. Presentations at the International Association for the Study of Lung Cancer (IASLC) 2022 World Conference on Lung Cancer (WCLC) Span Relapsed/Refractory Disease and Frontline Treatment in Patients with EGFR-Positive Non-Small Cell Lung Cancer July 26, 2022 (RARITAN, N.J.) WCLC 2020 News Japanese . Catherine A. Shu , Koichi Goto , Yuichiro Ohe Amivantamab, an EGFR-MET bispecific antibody with immune cell-directing activity, binds to each receptor's extracellular domain, bypassing resistance at the tyrosine kinase inhibitor binding site. January 28, 2021 (RARITAN, N.J.) - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data from the Phase 1 CHRYSALIS study, which evaluated amivantamab in patients with metastatic or unresectable non-small cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease progressed on or after platinum-based . [1]. In particular, lead-in sotorasib plus pembrolizumab induced deep responses. Punt about FOLFOXIRI + bevacizumab vs. FOLFOX/FOLFIRI + bevacizumab in patients with initially unresectable CRLM and right-sided and/or RAS/BRAFV600E-mutated primary tumour, Podcast with Prof. Christian Blank about personalised response-driven surgery and adjuvant therapy after neoadjuvant ipilimumab and nivolumab in resectable stage III melanoma, Podcast with Dr. Antonio Avallone and Dr. Alfredo Budillon about randomised intermittent or continuous panitumumab plus FOLFIRI for first-line treatment of patients with RAS/BRAF wild-type metastatic colorectal cancer, Dr. Kevin Punie talks us through some of the key data in the field of breast cancer, Prof. Dr. Hans Prenen shares his highlights in the field of gastro-intestinal cancer, Dr.Willem Lybaert discusses some of the key data in the field of head and neck cancer, Prof. Dr. Lore Decoster will walk us through the highlights in thoracic oncology, Dr. Daan De Maeseneer will share his highlights in the field of urogenital cancer, Podcast with Dr. Delvys Rodriguez-Abreu about pembrolizumab plus ipilimumab or placebo in previously untreated metastatic NSCLC with PD-L1 tumor proportion score 50%: 3-year follow-up of Keynote-598, Podcast with dr. Wainberg about the updated results from the phase III Keynote-062 trial, Podcast with dr. Antonio D'Alessio about real-world use of atezolizumab plus bevacizumab in patients with hepatocellular carcinoma and Child-Pugh A and B cirrhosis, Podcast with prof. Romain Cohen about one year of nivolumab plus ipilimumab for MSI/dMMR metastatic colorectal cancer patients, PODCAST with Prof. Michael Gnant about adjuvant palbociclib in HR+/HER2- early breast cancer - the final results from the PALLAS trial, Podcast with Prof. Dr. Sara Hurvitz about subgroup analyses from the randomised phase III DESTINY-Breast03 study, Podcast with Dr. Patricia Ganz about the quality of life results from the OlympiA trial, Professor Gerhardt Attard - Abiraterone acetate plus prednisolone (AAP) with or without enzalutamide (ENZ) added to androgen deprivation therapy (ADT) compared to ADT alone for men with high-risk non-metastatic (M0) prostate cancer (PCa), PODCAST of dr. Robin Cornelissen about efficacy and safety of poziotinib in treatment-nave NSCLC harboring HER2 exon 20 mutations, PODCAST of prof. dr. Helena Earl about Meta-Analysis of Reduced Duration adjuvant Trastuzumab in the treatment of HER2 positive Early Breast Cancer, PODCAST with prof. Eric Pujade-Lauraine about maintenance olaparib rechallenge in patients with ovarian carcinoma previously treated with a PARP inhibitor, PODCAST with Drs. Cohorts 1 and 2 tested the doublet approach, which was Dato-DXd 4mg/kg or 6mg/kg plus pembrolizumab Q3W, while Cohorts 3 to 6 were dedicated to the triplet regimens consisting of Dato-DXd 4mg/kg or 6mg/kg plus pembrolizumab and either carboplatin AUC5 (Cohorts 3 and 4) or carboplatin 75mg/m2 (Cohorts 5 and 6). Serious TRAEs were seen in 9% of patients, and 4% had treatment-related events that led to discontinuation. Lilly. 26 August 2022 COVID-19, SARS-CoV2, Cardiovascular, Infectious Disease Common Respiratory Viruses and Their Associated Cardiovascular Risks 11 August 2022 Cardiovascular Personalised Angina Treatment at Cellular Level Oncology 30 May 2022 COVID-19, SARS-CoV2, AIDS, HIV, Infectious Disease, Oncology, Vaccines Putting research into context. Oral daily sotorasib doses of 120mg, 240mg, 360mg, 720mg, and 960mg were tested. We are here to share treatment experiences, information about clinical trials, breaking news about research developments, and other information with each other. Median treatment duration was 6.5 months and median duration of response was not reached. What to look forward to at WCLC 2022? The first-in-class KRASG12C inhibitor sotorasib is being used as monotherapy for patients with pretreated KRASG12C-mutated advanced NSCLC. Seventy percent of patients were progression-free; in 2 additional cases, the treatment was ongoing beyond RECIST progression. 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O'Sullivan, Video interview with Professor E. van Cutsem, Video interview with Prof. Philippe Collard, Podcast with Prof. Erika Martinelli about evidence of therapeutic effectiveness of third-line cetuximab rechallenge in appropriately selected patients with metastatic colorectal cancer, Podcast with Prof. Arndt Vogel about the outcomes by baseline liver function in patients with unresectable hepatocellular carcinoma treated with tremelimumab and durvalumab in the Phase 3 HIMALAYA study, Podcast with Dr. Daniele Rossini about modified FOLFOXIRI plus panitumumab (mFOLFOXIRI/PAN) versus mFOLFOX6/PAN as initial treatment of unresectable RAS/BRAF wild-type metastatic colorectal cancer (mCRC) patients (TRIPLETE study), Podcast with Prof. Melina Marmarelis about the safety and efficacy of amivantamab and lazertinib in combination with platinum-based chemotherapy in relapsed/refractory EGFR-mutated NSCLC, Podcast with Prof. Johan Vansteenkiste about the challenges and opportunities with immunotherapy in the treatment of patients with squamous cell carcinoma of the lung, Podcast with Dr. Laurence Buisseret about first-line chemoimmunotherapy with durvalumab, paclitaxel, and carboplatin with or without the anti-CD73 antibody oleclumab to treat advanced or metastatic triple-negative breast cancer, Podcast with Prof. Richard S. Finn about lenvatinib plus pembrolizumab vs. lenvatinib as first-line therapy for advanced hepatocellular carcinoma, Podcast with Prof. Jean-Pascal Machiels about the primary results of the phase 3 KEYNOTE-412 study: pembrolizumab with chemoradiation vs. placebo plus chemoradiation for locally advanced head and neck squamous cell carcinoma, Podcast with Prof. Anne Demols and Prof. Francesco Sclafani about the highlights from ESMO 2022 on gastrointestinal cancer, Podcast with Prof. Christof Vulsteke about the highlights from ESMO 2022 on gynaecological cancer, Podcast with Dr. Willem Lybaert about the highlights from ESMO 2022 on head and neck cancer, Podcast with Prof. Lore Decoster about the highlights from ESMO 2022 on lung cancer, Designed by Ariez International BV, The Netherlands, Amivantamab monotherapy demonstrates antitumour activity in METex14 NSCLC. ASCO 2022 | Amivantamab updates confirm NSCLC efficacy for certain patients | medwirenews.com, 2022 ASCO Annual Meeting; Chicago, Illinois, USA: 37 June (Abstract 9006), 2022 ASCO Annual Meeting; Chicago, Illinois, USA: 37 June (Abstract 9008). Of the 54 patients with a response, 30 remained on treatment at data cutoff and 27 had responded for at least 6 months, the presenter noted. Amivantamab for Exon 20 Jan 31, 2021. WCLC (World Conference on Lung Cancer) 2022 Wrap Up September 25, 2022 Survey: 77% of Women With Lung Cancer Report Sexual Dysfunction September 25, 2022 Dr. Spira on the Further Investigations of Lazertinib/Amivantamab in EGFR-Mutant NSCLC September 25, 2022 Shu said the response to amivantamab plus lazertinib was consistent across patient subgroups including those with exon 19 deletion versus exon 21 L858R mutation. 2022 ASCOCHRYSALIS-2 Amivantamab+Lazertinib EGFR NSCLC EGFR TKI EGFR NSCLC EGFR TKI EGFR EGFR 24h--TRK! Safety constituted the primary endpoint. By WCLC 2022 Conference Coverage FEATURING Byoung Chul Cho. Acknowledging that amivantamab has a higher affinity to MET than EGFR, the researchers assessed the antibody as a monotherapy in a cohort of 55 patients with a primary MET exon 14 skipping mutation (METex14). Advances in precision oncology continue to facilitate drug development, allowing diseases like lung cancer to be subset into biomarker-defined populations appropriate for targeted therapies, Julia Beaver, MD, chief of medical oncology in the FDAs Oncology Center of Excellence, and acting deputy director of the Office of Oncologic Diseases in the FDAs Center for Drug Evaluation and Research, said in a press release. Stable disease was noted in 39 patients (48%), for a clinical benefit rate of 74% (95% CI, 63%-83%). They necessitated dose reductions and interruptions in 33.5% and 42.5%, respectively, although these patients were able to remain on treatment and continued to benefit. 1 Amivantamab and lazertinib with carboplatin and pemetrexed elicited an overall response rate of 50% (95% CI, 27%-73%) after a median follow-up of 7.1 months. The first targeted therapy for EGFR exon 20 insertion mutationpositive nonsmall cell lung cancer is now available for patients in the United States. : (NSCLC) In addition, the safety profile of amivantamab in this subgroup of patients with METex14 is consistent with previously reported experience of patients with EGFR-mutated NSCLC. In total, 58% of patients were non-smokers. Eight out of nine patients who responded are still in response. Background: Amivantamab is an epidermal growth factor receptor (EGFR)-MET bispecific antibody with immune cell-directing activity. The ORR was 33% among 46 evaluable patients overall but varied by subgroup at 57% for treatment-nave patients, 47% patients pretreated without a METTKI, and 17% for those who had previously received a METTKI. Since lazertinib/amivantamab has demonstrated the ability to overcome osimertinib resistance, investigators want to continue exploring optimal settings for the combinations use, Spira continues. Across all cohorts, deep and durable responses were noted, which included treatment at low doses. Pretreatment was allowed in the doublet group (median, 1 prior line), while the triplet group was treatment-nave. Amivantamab-vmjw (Rybrevant) was approved by the FDA as the first agent to treat adult patients with non-small cell lung cancer (NSCLC) whose tumors harbor EGFR exon 20 insertion mutations. Figure: Common adverse events with Dato-DXd plus pembrolizumab (doublet) and Dato-DXd plus pembrolizumab and platinum chemotherapy (triplet), Promising findings across oncogenic targets, This website is intended only for healthcare professionals outside the US, the UK, and Australia | This website is supported by an unrestricted medical education grant from Boehringer Ingelheim and BeiGene, Immune-based strategies are raising hope in small-cell tumors, Stage I-III disease: surgical and systemic options. May 21, 2021. Responses were obtained across all PD-L1 expression levels. The combination of lazertinib and amivantamab could have a role in several indications for patients with EGFR-mutated NSCLC, such as the in the treatment-nave setting or the refractory setting, Spira says. Four patients were treatment-nave. Median duration of response and median PFS were 20.8 and 13.8 months, thus exceeding the respective results observed in Cohort A (11.1 and 8.5 months). All rights reserved. medwireNews is an independent medical news service provided by Springer Healthcare Ltd. 2022 Springer Healthcare Ltd, part of the Springer Nature Group, 2022 ASCO Annual Meeting; Chicago, Illinois, USA: 37 June (Abstract 9006)2022 ASCO Annual Meeting; Chicago, Illinois, USA: 37 June (Abstract 9008), with trial summaries, expert opinion and congress coverage. CHRYSALIS is an ongoing phase I dose escalation/dose expansion study of amivantamab (140 - 1,750 mg) in patients with advanced NSCLC. In the METex14 cohort, patients with METex14 NSCLC whose disease progressed on or who declined current standard of care were treated at the recommended phase II dose of 1,050 mg (1,400 mg 80 kg) weekly in cycle 1 and biweekly thereafter. FDA2020WCLCICHRYSALISamivantamab-81EGFR 20insAmivantamab<80kg1050 mg80 kg1400 mg Read More . Treatment-related grade 3 adverse events were reported in three patients (16%) and included dyspnoea, hypoalbuminaemia and rash (N= 1, each). She said that the phase 3 MARIPOSA and MARIPOSA-2 trials are now investigating amivantamab plus lazertinib as a first-line regimen. The combination represents a chemotherapy-free regimen for this heavily treated patient population, the presenter observed. The EGFR kinase inhibitor mobocertinib and the bispecific-antibody amivantamab-vmjw appear to have similar efficacy for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have exon 20 insertion mutations in EGFR. Exemplary Education Responses proved durable; after a median follow-up of 7.1 months, 15 patients remained on treatment. Patients were equally divided between smokers (47%) and nonsmokers (53%). Adverse events (AEs) were mostly grade 1 and 2. All rights reserved. (WCLC) 2020 on January 29. . Given the bispecific nature of amivantamab, its role in patients with MET exon 14 skipping (METex14) mutations is now being explored (MET-2 cohort) in patients both nave to and refractory to other available MET therapy. 20225 (OS)24170% (PFS)7.3 (>20%) 4006-130-650! Median OS was 15.7 months for sotorasib plus any checkpoint inhibitor. Five percent of patients in the doublet group developed drug-related ILD grade 1/2; grade 3 events emerged in 3% and 2%, respectively.
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