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Article ; Online: Next-generation Sequencing of Cerebrospinal Fluid: How Can a Liquid be Like a Solid?

Marmarelis, Melina E / Bauml, Joshua M

Clinical cancer research : an official journal of the American Association for Cancer Research

2020 Volume 26, Issue 23, Page(s) 6077–6079

Abstract: The APOLLO investigators showed that next-generation sequencing of cerebrospinal fluid can reveal molecular alterations-how should this affect our management approach? ...

Abstract	The APOLLO investigators showed that next-generation sequencing of cerebrospinal fluid can reveal molecular alterations-how should this affect our management approach?
MeSH term(s)	Acrylamides ; Aniline Compounds ; Biomarkers ; Carcinoma, Non-Small-Cell Lung ; Central Nervous System ; ErbB Receptors ; High-Throughput Nucleotide Sequencing ; Humans ; Lung Neoplasms ; Mutation ; Protein Kinase Inhibitors
Chemical Substances	Acrylamides ; Aniline Compounds ; Biomarkers ; Protein Kinase Inhibitors ; osimertinib (3C06JJ0Z2O) ; EGFR protein, human (EC 2.7.10.1) ; ErbB Receptors (EC 2.7.10.1)
Language	English
Publishing date	2020-09-30
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Comment
ZDB-ID	1225457-5
ISSN	1557-3265 ; 1078-0432
ISSN (online)	1557-3265
ISSN	1078-0432
DOI	10.1158/1078-0432.CCR-20-3330
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Zs.A 4223: Show issues

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Article: Immunotherapy for head and neck cancer: where are we now and where are we going?

Bauml, Joshua M / Aggarwal, Charu / Cohen, Roger B

Annals of translational medicine

2019 Volume 7, Issue Suppl 3, Page(s) S75

Language	English
Publishing date	2019-09-25
Publishing country	China
Document type	Editorial ; Comment
ZDB-ID	2893931-1
ISSN	2305-5847 ; 2305-5839
ISSN (online)	2305-5847
ISSN	2305-5839
DOI	10.21037/atm.2019.03.58
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Article: Sex-Related Differences in Outcomes for Oropharyngeal Squamous Cell Carcinoma by HPV Status.

Kao, Derek D / Ferrandino, Rocco M / Marshall, Deborah C / Mutetwa, Tinaye / Miles, Brett / Bauml, Joshua M / Sigel, Keith M

International journal of otolaryngology

2022 Volume 2022, Page(s) 4220434

Abstract: Background: Overall survival for HPV-associated oropharyngeal squamous cell carcinoma (OPSCC) has differed by sex, but little is known regarding cancer-specific outcomes. We assessed the independent association of sex with cancer-specific survival in ... ...

Abstract	Background: Overall survival for HPV-associated oropharyngeal squamous cell carcinoma (OPSCC) has differed by sex, but little is known regarding cancer-specific outcomes. We assessed the independent association of sex with cancer-specific survival in patients with HPV-associated oropharyngeal squamous cell carcinoma (OPSCC). Methods: We identified 14,183 patients from the Surveillance, Epidemiology, and End Results (SEER) program with OPSCC and tumor HPV status. We used Kaplan-Meier methods to compare overall survival (OS) and OPSCC-specific survival (HNCSS) by patient sex and by tumor HPV status. We then separately fit multivariable survival and competing risk models evaluating the association of sex on these outcomes by tumor HPV status and stratified by the use of guideline-concordant OPSCC treatment. Results: A total of 10,210 persons with HPV-positive tumors (72.0%) and 3,973 with HPV-negative tumors (28.0%) were identified. A larger proportion of women had HPV-negative tumors (24.0%) versus HPV-positive tumors (13.2%; Conclusions: Women with HPV-positive OPSCC had similar survival outcomes compared to men, but those with HPV-negative tumors have worse overall and cancer-specific survival.
Language	English
Publishing date	2022-05-02
Publishing country	United States
Document type	Journal Article
ZDB-ID	2503281-1
ISSN	1687-921X ; 1687-9201
ISSN (online)	1687-921X
ISSN	1687-9201
DOI	10.1155/2022/4220434
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Article ; Online: Prophylactic feeding tube placement for squamous cell carcinoma of the head and neck.

Kao, Derek D / Ferrandino, Rocco M / Bauml, Joshua M / Marshall, Deborah C / Bakst, Richard / Roof, Scott / Park, Yeun-Hee A / Sigel, Keith M

Oral oncology

2022 Volume 135, Page(s) 106216

Abstract: Background: Percutaneous endoscopic gastronomy (PEG) tubes are commonly used to administer enteral nutrition during head and neck cancer (HNC) treatment. However, the benefits of placing a prophylactic feeding tube (PFT; prior to radiotherapy [RT]) or ... ...

Abstract	Background: Percutaneous endoscopic gastronomy (PEG) tubes are commonly used to administer enteral nutrition during head and neck cancer (HNC) treatment. However, the benefits of placing a prophylactic feeding tube (PFT; prior to radiotherapy [RT]) or reactive feeding tube (RFT, after RT initiation) are unclear. We sought to compare survival, body mass trends, and hospitalization rates between strategies. Methods: We conducted a retrospective cohort study of 11,473 Veterans with stages III-IVC HNC treated with chemoradiotherapy. Patients with PEG tube placement within 30 days prior to treatment initiation (PFT) were compared to all other patients (non-PFT) or patients with PEG tube placement within 3 months after treatment initiation placement (RFT). We compared survival, longitudinal body mass changes, and hospitalization rates for PFT versus non-PFT or RFT patients in propensity score (PS)-matched Cox regression models. Results: 3,186 (28 %) patients received PFT and 8,287 (72 %) were non-PFT, of which 1,874 (23 %) received RFT. After PS-matching, there were no significant differences in overall survival (HR 0.97, 95 % CI 0.92-1.02), HNC-specific survival (HR 0.98, 95 % CI 0.92-1.09), change in BMI (p = 0.24), or hospitalization rates between PFT and non-PFT groups. Significant differences in hospitalization rates between PFT and RFT groups persisted after PS-matching (-0.11 hospitalizations/month), but no differences were found for other outcomes. Conclusion: Timing of PEG tube placement in Veterans with HNC was not associated with any significant survival or body mass advantage. However, patients who received PFT had a lower hospitalization rate than those who received RFT.
MeSH term(s)	Humans ; Squamous Cell Carcinoma of Head and Neck/etiology ; Retrospective Studies ; Intubation, Gastrointestinal ; Gastrostomy/adverse effects ; Carcinoma, Squamous Cell/etiology ; Head and Neck Neoplasms/etiology
Language	English
Publishing date	2022-10-28
Publishing country	England
Document type	Journal Article
ZDB-ID	1120465-5
ISSN	1879-0593 ; 0964-1955 ; 1368-8375
ISSN (online)	1879-0593
ISSN	0964-1955 ; 1368-8375
DOI	10.1016/j.oraloncology.2022.106216
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Zs.A 4869: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
Zs.A 456: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)

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Article: Immunotherapy for head and neck cancer: latest developments and clinical potential.

Bauml, Joshua M / Cohen, Roger B / Aggarwal, Charu

Therapeutic advances in medical oncology

2016 Volume 8, Issue 3, Page(s) 168–175

Abstract: Head and neck squamous cell cancer (HNSCC) is a malignancy with a rapidly changing demographic profile, given the recent epidemic of human papilloma virus related cancers. Most patients present with locally advanced disease and receive combination ... ...

Abstract	Head and neck squamous cell cancer (HNSCC) is a malignancy with a rapidly changing demographic profile, given the recent epidemic of human papilloma virus related cancers. Most patients present with locally advanced disease and receive combination therapeutic approaches with curative potential, albeit with significant toxicity. Up to a third of patients, however, will eventually develop recurrent or metastatic disease. The prognosis of such patients is dismal, as palliative treatment options remain limited. Immune-directed therapies offer a novel therapeutic strategy beyond cytotoxic chemotherapy and are currently being evaluated in a wide variety of malignancies. HNSCC is a particularly favorable disease for immunotherapy, as immune evasion and dysregulation have been shown to play a key role in the initiation and progression of HNSCC. This review focuses on the latest developments in immunotherapy in HNSCC, with a particular focus on checkpoint inhibitors, adoptive cellular therapies, and vaccines.
Language	English
Publishing date	2016-02-16
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	2503443-1
ISSN	1758-8359 ; 1758-8340
ISSN (online)	1758-8359
ISSN	1758-8340
DOI	10.1177/1758834016631529
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Article ; Online: Management of infusion-related reactions (IRRs) in patients receiving amivantamab in the CHRYSALIS study.

Park, Keunchil / Sabari, Joshua K / Haura, Eric B / Shu, Catherine A / Spira, Alexander / Salgia, Ravi / Reckamp, Karen L / Sanborn, Rachel E / Govindan, Ramaswamy / Bauml, Joshua M / Curtin, Joshua C / Xie, John / Roshak, Amy / Lorenzini, Patricia / Millington, Dawn / Thayu, Meena / Knoblauch, Roland E / Cho, Byoung Chul

Lung cancer (Amsterdam, Netherlands)

2023 Volume 178, Page(s) 166–171

Abstract: Background: Amivantamab, a fully humanized EGFR-MET bispecific antibody, has antitumor activity in diverse EGFR- and MET-driven non-small cell lung cancer (NSCLC) and a safety profile consistent with associated on-target activities. Infusion-related ... ...

Abstract	Background: Amivantamab, a fully humanized EGFR-MET bispecific antibody, has antitumor activity in diverse EGFR- and MET-driven non-small cell lung cancer (NSCLC) and a safety profile consistent with associated on-target activities. Infusion-related reaction(s) (IRR[s]) are reported commonly with amivantamab. We review IRR and subsequent management in amivantamab-treated patients. Methods: Patients treated with the approved dose of intravenous amivantamab (1050 mg, <80 kg; 1400 mg, ≥80 kg) in CHRYSALIS-an ongoing, phase 1 study in advanced EGFR-mutated NSCLC-were included in this analysis. IRR mitigations included split first dose (350 mg, day 1 [D1]; remainder, D2), reduced initial infusion rates with proactive infusion interruption, and steroid premedication before initial dose. For all doses, pre-infusion antihistamines and antipyretics were required. Steroids were optional after the initial dose. Results: As of 3/30/2021, 380 patients received amivantamab. IRRs were reported in 256 (67%) patients. Signs/symptoms of IRR included chills, dyspnea, flushing, nausea, chest discomfort, and vomiting. Most of the 279 IRRs were grade 1 or 2; grade 3 and 4 IRR occurred in 7 and 1 patients, respectively. Most (90%) IRRs occurred on cycle 1, D1 (C1D1); median time-to-first-IRR onset during C1D1 was 60 min; and first-infusion IRRs did not compromise subsequent infusions. Per protocol, IRR was mitigated on C1D1 with holding of infusion (56% [214/380]), reinitiating at reduced rate (53% [202/380]), and aborting infusion (14% [53/380]). C1D2 infusions were completed in 85% (45/53) of patients who had C1D1 infusions aborted. Four patients (1% [4/380]) discontinued treatment due to IRR. In studies aimed at elucidating the underlying mechanism(s) of IRR, no pattern was observed between patients with versus without IRR. Conclusion: IRRs with amivantamab were predominantly low grade and limited to first infusion, and rarely occurred with subsequent dosing. Close monitoring for IRR with the initial amivantamab dose and early intervention at first IRR signs/symptoms should be part of routine amivantamab administration.
MeSH term(s)	Animals ; Humans ; Antibodies, Bispecific ; Carcinoma, Non-Small-Cell Lung/drug therapy ; Drug-Related Side Effects and Adverse Reactions ; ErbB Receptors ; Immune System Diseases ; Lung Neoplasms ; Pupa
Chemical Substances	amivantamab-vmjw ; Antibodies, Bispecific ; ErbB Receptors (EC 2.7.10.1)
Language	English
Publishing date	2023-02-15
Publishing country	Ireland
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	632771-0
ISSN	1872-8332 ; 0169-5002
ISSN (online)	1872-8332
ISSN	0169-5002
DOI	10.1016/j.lungcan.2023.02.008
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Article ; Online: A Phase II Open-Label Trial of Binimetinib and Hydroxychloroquine in Patients With Advanced KRAS-Mutant Non-Small Cell Lung Cancer.

Aggarwal, Charu / Maity, Alisha P / Bauml, Joshua M / Long, Qi / Aleman, Tomas / Ciunci, Christine / D'Avella, Christopher / Volpe, Melissa / Anderson, Evan / Jones, Lisa McCormick / Sun, Lova / Singh, Aditi P / Marmarelis, Melina E / Cohen, Roger B / Langer, Corey J / Amaravadi, Ravi

The oncologist

2023 Volume 28, Issue 7, Page(s) 644–e564

Abstract: Background: In RAS-mutant tumors, combined MEK and autophagy inhibition using chloroquine demonstrated synthetic lethality in preclinical studies. This phase II trial evaluated the safety and activity of the MEK inhibitor binimetinib combined with ... ...

Abstract	Background: In RAS-mutant tumors, combined MEK and autophagy inhibition using chloroquine demonstrated synthetic lethality in preclinical studies. This phase II trial evaluated the safety and activity of the MEK inhibitor binimetinib combined with hydroxychloroquine (HCQ) in patients with advanced KRAS-mutant non-small cell lung cancer (NSCLC). Methods: Eligibility criteria included KRAS-mutant NSCLC, progression after first-line therapy, ECOG PS 0-1, and adequate end-organ function. Binimetinib 45 mg was administered orally (p.o.) bid with HCQ 400 mg p.o. bid. The primary endpoint was objective response rate (ORR). A Simon's 2-stage phase II clinical trial design was used, with an α error of 5% and a power β of 80%, anticipating an ORR of 30% to proceed to the 2-stage expansion. Results: Between April 2021 and January 2022, 9 patients were enrolled to stage I: median age 64 years, 44.4% females, 78% smokers. The best response was stable disease in one patient (11.1%). The median progression free survival (PFS) was 1.9 months, and median overall survival (OS) was 5.3 months. Overall, 5 patients (55.6%) developed a grade 3 adverse event (AE). The most common grade 3 toxicity was rash (33%). Pre-specified criteria for stopping the trial early due to lack of efficacy were met. Conclusion: The combination of B + HCQ in second- or later-line treatment of patients with advanced KRAS-mutant NSCLC did not show significant antitumor activity. (ClinicalTrials.gov Identifier: NCT04735068).
MeSH term(s)	Female ; Humans ; Male ; Middle Aged ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Carcinoma, Non-Small-Cell Lung/drug therapy ; Carcinoma, Non-Small-Cell Lung/genetics ; Hydroxychloroquine/adverse effects ; Hydroxychloroquine/therapeutic use ; Lung Neoplasms/drug therapy ; Lung Neoplasms/genetics ; Mitogen-Activated Protein Kinase Kinases ; Mutation ; Proto-Oncogene Proteins p21(ras)/genetics
Chemical Substances	binimetinib (181R97MR71) ; Hydroxychloroquine (4QWG6N8QKH) ; KRAS protein, human ; Mitogen-Activated Protein Kinase Kinases (EC 2.7.12.2) ; Proto-Oncogene Proteins p21(ras) (EC 3.6.5.2)
Language	English
Publishing date	2023-04-25
Publishing country	England
Document type	Clinical Trial, Phase II ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1409038-7
ISSN	1549-490X ; 1083-7159
ISSN (online)	1549-490X
ISSN	1083-7159
DOI	10.1093/oncolo/oyad106
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Zs.A 4845: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
Zs.MO 494: Show issues

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Article ; Online: Frequency, underdiagnosis, and heterogeneity of epidermal growth factor receptor exon 20 insertion mutations using real-world genomic datasets.

Viteri, Santiago / Minchom, Anna / Bazhenova, Lyudmila / Ou, Sai-Hong Ignatius / Bauml, Joshua M / Shell, Scott A / Schaffer, Michael / Gu, Junchen / Rose, Jennifer B / Curtin, Joshua C / Mahadevia, Parthiv / Girard, Nicolas

Molecular oncology

2022 Volume 17, Issue 2, Page(s) 230–237

Abstract: Epidermal growth factor receptor (EGFR) exon 20 insertion mutations (ex20ins) account for ≤ 12% of all EGFR-mutant nonsmall cell lung cancers. We analysed real-world datasets to determine the frequency of ex20ins variants, and the ability of polymerase ... ...

Abstract	Epidermal growth factor receptor (EGFR) exon 20 insertion mutations (ex20ins) account for ≤ 12% of all EGFR-mutant nonsmall cell lung cancers. We analysed real-world datasets to determine the frequency of ex20ins variants, and the ability of polymerase chain reaction (PCR) and next-generation sequencing (NGS) to identify them. Three real-world United States NGS databases were used: GENIE, FoundationInsights, and GuardantINFORM. Mutation profiles consistent with in-frame EGFR ex20ins were summarized. GENIE, FoundationInsights, and GuardantINFORM datasets identified 180, 627, and 627 patients with EGFR ex20ins respectively. The most frequent insertion region of exon 20 was the near loop (~ 70%), followed by the far loop (~ 30%) and the helical (~ 3-6%) regions. GENIE, FoundationInsights, and GuardantINFORM datasets identified 41, 102, and 96 unique variants respectively. An analysis of variants projected that ~ 50% of EGFR ex20ins identified by NGS would have been missed by PCR-based assays. Given the breadth of EGFR ex20ins identified in the real-world US datasets, the ability of PCR to identify these mutations is limited. NGS platforms are more appropriate to identify patients likely to benefit from EGFR ex20ins-targeted therapies.
MeSH term(s)	Humans ; Lung Neoplasms/diagnosis ; Lung Neoplasms/genetics ; Mutagenesis, Insertional/genetics ; ErbB Receptors/genetics ; Mutation/genetics ; Exons/genetics ; Genomics ; Protein Kinase Inhibitors
Chemical Substances	ErbB Receptors (EC 2.7.10.1) ; Protein Kinase Inhibitors
Language	English
Publishing date	2022-11-28
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2415106-3
ISSN	1878-0261 ; 1574-7891
ISSN (online)	1878-0261
ISSN	1574-7891
DOI	10.1002/1878-0261.13327
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Article ; Online: Comparative Clinical Outcomes Between EGFR Ex20ins and Wildtype NSCLC Treated with Immune Checkpoint Inhibitors.

Girard, Nicolas / Minchom, Anna / Ou, Sai-Hong Ignatius / Gadgeel, Shirish M / Trigo, José / Viteri, Santiago / Bauml, Joshua M / Londhe, Anil / Mahadevia, Parthiv / Bazhenova, Lyudmila

Clinical lung cancer

2022 Volume 23, Issue 7, Page(s) 571–577

Abstract: Introduction: The activity of immune checkpoint inhibitors (ICIs) in NSCLC harboring EGFR exon 20 insertion mutations (ex20ins) has not been closely examined due to the frequent exclusion of patients with EGFR mutations from large immunotherapy-based ... ...

Abstract	Introduction: The activity of immune checkpoint inhibitors (ICIs) in NSCLC harboring EGFR exon 20 insertion mutations (ex20ins) has not been closely examined due to the frequent exclusion of patients with EGFR mutations from large immunotherapy-based NSCLC trials. Patients and methods: A real-world, retrospective study was conducted to compare outcomes of ICI-treated patients with EGFR ex20ins and wildtype NSCLC (wt-NSCLC; defined as EGFR and ALK test negative). Patients with advanced NSCLC from the Flatiron Health database (2015-2020) were included in the analysis. Real-world time to next therapy (rwTTNT) and overall survival (rwOS), stratified by ICI initiation line of therapy, were the prespecified primary and secondary endpoints, respectively. Results: Among 59 patients with EGFR ex20ins NSCLC and 5365 with wt-NSCLC, ICI treatment was received as first-line therapy in 25% and 39%, respectively. Patients with EGFR ex20ins had a 58% increased risk of shorter time to next-line therapy compared with wt-NSCLC (adjusted hazard ratio of 1.58 [95% confidence interval [CI], 1.2-2.1]; P = .0012). The median rwTTNT for first ICI line was 3.7 months (95% CI, 3.0-4.9) for EGFR ex20ins NSCLC compared with 5.8 months (95% CI, 5.6-6.0) for wt-NSCLC. No meaningful difference in rwOS between the groups was observed. Conclusions: ICI therapy may be less effective for patients with EGFR ex20ins compared with wt-NSCLC. Consistent with prior data on exon 19 deletion and L858R substitution, tumors harboring ex20ins appear to be less responsive to immune checkpoint inhibition than wt-NSCLC.
MeSH term(s)	Humans ; Carcinoma, Non-Small-Cell Lung/drug therapy ; Carcinoma, Non-Small-Cell Lung/genetics ; Carcinoma, Non-Small-Cell Lung/pathology ; ErbB Receptors/genetics ; Immune Checkpoint Inhibitors/therapeutic use ; Lung Neoplasms/drug therapy ; Lung Neoplasms/genetics ; Lung Neoplasms/pathology ; Mutation/genetics ; Retrospective Studies
Chemical Substances	ErbB Receptors (EC 2.7.10.1) ; Immune Checkpoint Inhibitors
Language	English
Publishing date	2022-07-21
Publishing country	United States
Document type	Comparative Study ; Journal Article
ZDB-ID	2145146-1
ISSN	1938-0690 ; 1525-7304
ISSN (online)	1938-0690
ISSN	1525-7304
DOI	10.1016/j.cllc.2022.07.007
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Article ; Online: Amivantamab compared with real-world therapies in patients with advanced non-small cell lung cancer harboring EGFR exon 20 insertion mutations who progressed after platinum-based chemotherapy.

Minchom, Anna / Viteri, Santiago / Bazhenova, Lyudmila / Gadgeel, Shirish M / Ou, Sai-Hong Ignatius / Trigo, José / Bauml, Joshua M / Backenroth, Daniel / Bhattacharya, Archan / Li, Tracy / Mahadevia, Parthiv / Girard, Nicolas

Lung cancer (Amsterdam, Netherlands)

2022 Volume 168, Page(s) 74–82

Abstract: Background: In the single-arm CHRYSALIS study, amivantamab showed durable responses and manageable safety in patients with advanced non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations (ex20ins) ...

Abstract	Background: In the single-arm CHRYSALIS study, amivantamab showed durable responses and manageable safety in patients with advanced non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations (ex20ins) who progressed on prior platinum-based chemotherapy. External controls can provide context for interpreting amivantamab efficacy. Methods: External controls were selected from three US-based databases (ConcertAI, COTA, and Flatiron). Key inclusion criteria were diagnosis of EGFR ex20ins advanced NSCLC, prior platinum-based chemotherapy, and performance status score ≤ 1. Duplicate external controls were identified using a tokenization procedure and removed, and adjustment for differences in baseline characteristics between amivantamab-treated and external control cohorts was achieved using propensity score weighting. Results: Amivantamab-treated and pooled external control cohorts included 81 and 125 patients, respectively. Baseline characteristics were generally similar across cohorts, except more amivantamab-treated patients were Asian (56% vs 13%). Most common therapies received by external controls were non-platinum-based chemotherapy (25.1%), immuno-oncology therapies (24.2%), EGFR tyrosine kinase inhibitors (16.3%), and platinum-based chemotherapy (16.3%). Overall response rate was 40% among amivantamab-treated patients and 16% among external controls. Amivantamab-treated patients had longer progression-free survival (median 8.3 vs 2.9 months; hazard ratio [HR; 95% CI]: 0.47 [0.34-0.65]), time to next therapy (median 14.8 vs 4.8 months; HR [95% CI]: 0.40 [0.28-0.57]), and overall survival (median 22.8 vs 12.8 months; HR [95% CI]: 0.49 [0.31-0.77]) than external controls. Results were consistent in sensitivity analyses comparing each external control dataset against the amivantamab-treated group separately. Conclusion: Among post-platinum patients with EGFR ex20ins advanced NSCLC, those treated with amivantamab had improved outcomes, including 10-month longer overall survival, versus external controls.
MeSH term(s)	Antibodies, Bispecific ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Carcinoma, Non-Small-Cell Lung/drug therapy ; Carcinoma, Non-Small-Cell Lung/genetics ; ErbB Receptors ; Exons ; Humans ; Lung Neoplasms/chemically induced ; Lung Neoplasms/drug therapy ; Lung Neoplasms/genetics ; Mutagenesis, Insertional ; Mutation ; Platinum/therapeutic use ; Protein Kinase Inhibitors/therapeutic use
Chemical Substances	Antibodies, Bispecific ; Protein Kinase Inhibitors ; amivantamab-vmjw ; Platinum (49DFR088MY) ; EGFR protein, human (EC 2.7.10.1) ; ErbB Receptors (EC 2.7.10.1)
Language	English
Publishing date	2022-03-08
Publishing country	Ireland
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	632771-0
ISSN	1872-8332 ; 0169-5002
ISSN (online)	1872-8332
ISSN	0169-5002
DOI	10.1016/j.lungcan.2022.03.005
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