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Displaying One Session

Channel 1 Proffered Paper session
Date
20.09.2020
Time
14:25 - 16:05
Room
Channel 1
Chairs
  • Lecia V. Sequist (Boston, MA, United States of America)
  • Natasha Leighl (Toronto, Canada)
Proffered Paper - NSCLC metastatic 1 Proffered Paper session

1257O - Durability of clinical benefit and biomarkers in patients (pts) with advanced non-small cell lung cancer (NSCLC) treated with AMG 510 (sotorasib)

Presentation Number
1257O
Lecture Time
14:25 - 14:37
Speakers
  • David S. Hong (Houston, United States of America)
Room
Channel 1
Date
20.09.2020
Time
14:25 - 16:05

Abstract

Background

The phase 1 trial of sotorasib, a KRASG12C inhibitor, demonstrated a favorable safety profile and preliminary antitumor activity in pts with advanced solid tumors harboring KRAS p.G12C. Here, we present durability of clinical benefit and biomarker data in pts with NSCLC.

Methods

Key eligibility criteria include KRAS p.G12C mutation and prior systemic anticancer treatment (tx). Primary endpoint is safety; key secondary endpoints include objective response rate (ORR), disease control rate (DCR), duration of response (DOR), and progression-free survival (PFS). KRAS p.G12C mutant allele frequency (MAF) and PD-L1 level were examined.

Results

As of July 17, 2019, 40 pts with NSCLC (22 female [55.0%], median age: 68.0 years [range: 49-77]) were enrolled. Data cutoff date was March 25, 2020. 31 (77.5%) and 19 pts (47.5%) received ≥ 2 and 3 prior lines of therapy, respectively. Median follow-up was 10.2 (range: 8.3–19.0) months (mos). 3 pts (7.5%) had adverse events leading to discontinuation. There were no dose-limiting toxicities or fatal tx-related adverse events. Median PFS for all pts was 6.9 (range: 1.2–13.9) mos. ORR was 30% (95% Cl, 16.56–46.53). DOR ranged from 1.6 (+) to 12.7 mos, with 7 of 12 responders still in response at data cutoff. DCR was 92.5% (95% Cl, 79.61–98.43). 18 pts (45.0%) had progressive disease. At data cutoff, 10 pts (25.0%) were on study without disease progression, and 9 pts (22.5%) died. 18 pts (45.0%) (5 partial response (PR), 12 stable disease (SD), 1 progressive disease (PD)) had KRAS p.G12C MAF data available. There was no significant association between KRAS p.G12C MAF and response (Wilcoxon P = 0.80 for PR vs SD). 11 pts (27.5%) had PD-L1 data available. The median PD-L1 tumor proportion score [TPS] was 3% (range: 1–5) in 2 pts with PR, 0% (range: 0–0) in 8 pts with SD, and 75% (range: 75–75) in the pt with PD (Wilcoxon P = 0.044 for PR vs. SD).

Conclusions

In pts with heavily pretreated NSCLC, durable responses to sotorasib were seen, with the majority of pts achieving disease control leading to a median PFS of 6.9 months. The current limited dataset suggests that neither KRAS p.G12C MAF nor PD-L1 expression level predicts response to sotorasib.

Clinical trial identification

NCT03600883.

Editorial acknowledgement

Medical writing support was provided by Liz Leight (Amgen Inc.).

Legal entity responsible for the study

Amgen Inc.

Funding

Amgen Inc.

Disclosure

D.S. Hong: Research grant/Funding (institution), Non-remunerated activity/ies, Other: Bayer; Research grant/Funding (institution): Lilly; Research grant/Funding (institution): Genentech; Honoraria (self), Research grant/Funding (institution): Loxo; Research grant/Funding (institution): Pfizer; Research grant/Funding (institution): Amgen; Research grant/Funding (institution): Mirati; Research grant/Funding (institution): Ignyta; Research grant/Funding (institution): Merck; Research grant/Funding (institution): Daiichi Sanko; Research grant/Funding (institution): Eisai; Research grant/Funding (institution): Adaptimmune; Research grant/Funding (institution): AbbVie; Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): BMS; Research grant/Funding (institution): Genmab; Research grant/Funding (institution): Infinity; Research grant/Funding (institution): Kite; Research grant/Funding (institution): Kyowa; Research grant/Funding (institution): MedImmune; Research grant/Funding (institution): Molecular Template; Research grant/Funding (institution): Novartis; Research grant/Funding (institution): Takeda; Honoraria (self): Mirna; Non-remunerated activity/ies, Other: Baxter; Non-remunerated activity/ies, Other: Guidepoint Global; Non-remunerated activity/ies, Other: Oncoresponse; Non-remunerated activity/ies, Other: Janssen; Non-remunerated activity/ies, Other: Molecular Match. Y-J. Bang: Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca; Advisory/Consultancy, Research grant/Funding (institution): Novartis; Advisory/Consultancy, Research grant/Funding (institution): Genentech/Roche; Advisory/Consultancy, Research grant/Funding (institution): MSD; Advisory/Consultancy, Research grant/Funding (institution): Merck Serano; Advisory/Consultancy, Research grant/Funding (institution): Bayer; Advisory/Consultancy, Research grant/Funding (institution): BMS; Advisory/Consultancy, Research grant/Funding (institution): Eli Lilly; Advisory/Consultancy, Research grant/Funding (institution): Taiho; Advisory/Consultancy, Research grant/Funding (institution): Daiich-Sankyo; Advisory/Consultancy, Research grant/Funding (institution): Astellas; Advisory/Consultancy, Research grant/Funding (institution): BeiGene; Advisory/Consultancy, Research grant/Funding (institution): GreenCross; Advisory/Consultancy: Samyang Biopharm; Advisory/Consultancy: Hanmi; Advisory/Consultancy, Research grant/Funding (institution): Genexine; Research grant/Funding (institution): GSK; Research grant/Funding (institution): Pfizer; Research grant/Funding (institution): Boehringer Ingelheim; Research grant/Funding (institution): MacroGenics; Research grant/Funding (institution): Boston Biomedical; Research grant/Funding (institution): FivePrime; Research grant/Funding (institution): Curis; Research grant/Funding (institution): Takeda; Research grant/Funding (institution): Ono; Research grant/Funding (institution): CKD Pharma. F. Barlesi: Honoraria (self), Research grant/Funding (institution), Non-remunerated activity/ies, Principal Investigator for clinical trial: AstraZeneca; Honoraria (self), Research grant/Funding (institution): Bayer; Honoraria (self), Research grant/Funding (institution), Non-remunerated activity/ies, Principal Investigator for clinical trial: Bristol-Myers Squibb; Honoraria (self), Research grant/Funding (institution): Boehringer–Ingelheim; Honoraria (self), Research grant/Funding (institution): Eli Lilly Oncology; Honoraria (self), Research grant/Funding (institution), Non-remunerated activity/ies, Principal Investigator for clinical trial: F. Hoffmann–La Roche Ltd; Honoraria (self), Research grant/Funding (institution): Novartis; Honoraria (self), Research grant/Funding (institution), Non-remunerated activity/ies, Principal Investigator for clinical trial: Merck; Honoraria (self), Research grant/Funding (institution): MSD; Honoraria (self), Research grant/Funding (institution), Non-remunerated activity/ies, Principal Investigator for clinical trial: Pierre Fabre; Honoraria (self), Research grant/Funding (institution): Pfizer; Honoraria (self), Research grant/Funding (institution): Takeda; Research grant/Funding (institution): AbbVie; Research grant/Funding (institution): ACEA; Research grant/Funding (institution): Amgen; Research grant/Funding (institution): Eisai; Research grant/Funding (institution): Genentech; Research grant/Funding (institution): Ipsen; Research grant/Funding (institution): Ignyta; Research grant/Funding (institution): Innate Pharma; Research grant/Funding (institution): Loxo; Research grant/Funding (institution): MedImmune; Research grant/Funding (institution): Sanofi-Aventis .G.A. Durm: Research grant/Funding (institution): Merck; Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): Bristol-Myers Squibb; Non-remunerated activity/ies: Amgen. G.S. Falchook: Honoraria (self): Wolters Kluwer; Advisory/Consultancy, Travel/Accommodation/Expenses: FujiFilm; Travel/Accommodation/Expenses: Bristol-Myers Squibb; Travel/Accommodation/Expenses: Sarah Cannon Research Institute; Speaker Bureau/Expert testimony: Total Health Conferencing; Research grant/Funding (institution): 3-V Biosciences; Research grant/Funding (institution): AbbVie; Research grant/Funding (institution): ADC Therapeutics; Research grant/Funding (institution): Aileron; Research grant/Funding (institution): American Society of Clinical Oncology; Research grant/Funding (institution): Amgen; Research grant/Funding (institution): ARMO; Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): BeiGene; Research grant/Funding (institution): Bioatla; Research grant/Funding (institution): Biothera; Research grant/Funding (institution): Celldex; Research grant/Funding (institution): Celgene; Research grant/Funding (institution): Ciclomed; Speaker Bureau/Expert testimony: Rocky Mountain Oncology Society ; Research grant/Funding (institution): Curegenix; Research grant/Funding (institution): Curis; Research grant/Funding (institution): Cyteir; Research grant/Funding (institution): Daiichi; Research grant/Funding (institution): DelMar; Research grant/Funding (institution): eFFECTOR; Research grant/Funding (institution): Eli Lilly; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: EMD Serono; Research grant/Funding (institution): Epizyme, Exelixis, Fujifilm, Genmab, GlaxoSmithKline, Hutchison MediPharma, Ignyta, Incyte, Jacobio, Jounce, Kolltan, Loxo, MedImmune, Millennium, Merck, miRNA Therapeutics, National Institutes of Health, Novartis, OncoMed, Oncorus; Research grant/Funding (institution): Oncothyreon, Poseida, Precision Oncology, Prelude, Regeneron, Rgenix, Ribon, Strategia, Syndax, Taiho, Takeda, Tarveda, Tesaro, Tocagen, Turning Point Therapeutics, U.T. MD Anderson Cancer Center, Vegenics, Xencor. K. Park: Advisory/Consultancy: Amgen. J.H. Strickler: Advisory/Consultancy, Research grant/Funding (institution): Amgen. T.F. Burns: Advisory/Consultancy: Novartis; Advisory/Consultancy: Blueprint Medicine; Advisory/Consultancy: Thermo Fisher Scientific. J. Kim: Shareholder/Stockholder/Stock options, Full/Part-time employment: Amgen. A. Ang: Shareholder/Stockholder/Stock options, Full/Part-time employment: Amgen. J.R. Lipford: Shareholder/Stockholder/Stock options, Full/Part-time employment: Amgen. G. Ngarmchamnanrith: Shareholder/Stockholder/Stock options, Full/Part-time employment: Amgen. A. Anderson: Shareholder/Stockholder/Stock options, Full/Part-time employment: Amgen. B.T. Li: Advisory/Consultancy, Research grant/Funding (institution): Genentech/Roche; Advisory/Consultancy: Thermo Fisher Scientific; Advisory/Consultancy, Research grant/Funding (institution): Guardant Health; Advisory/Consultancy, Research grant/Funding (institution): Hengrui Therapeutics; Advisory/Consultancy: Mersana Therapeutics; Advisory/Consultancy, Research grant/Funding (institution): Eli Lilly; Travel/Accommodation/Expenses: Resolution Bioscience; Research grant/Funding (institution), Travel/Accommodation/Expenses: MORE Health; Research grant/Funding (institution): Amgen; Research grant/Funding (institution): Daiichi Sankyo; Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): BioMedValley Discoveries; Research grant/Funding (institution): Illumina; Research grant/Funding (institution): GRAIL. All other authors have declared no conflicts of interest.

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Proffered Paper - NSCLC metastatic 1 Proffered Paper session

1258O - Amivantamab (JNJ-61186372), an EGFR-MET bispecific antibody, in combination with lazertinib, a 3rd-generation tyrosine kinase inhibitor (TKI), in advanced EGFR NSCLC

Presentation Number
1258O
Lecture Time
14:37 - 14:49
Speakers
  • Byoung Chul Cho (Seoul, Korea, Republic of)
Room
Channel 1
Date
20.09.2020
Time
14:25 - 16:05

Abstract

Background

In preclinical studies, the combination of amivantamab (EGFR-MET bispecific antibody) with lazertinib demonstrates synergistic inhibition of tumor growth. We present the safety and early efficacy results of patients receiving amivantamab in combination with lazertinib in the phase 1 CHRYSALIS study (NCT02609776).

Methods

Patients with EGFR Exon 19 deletion or L858R mutation non-small cell lung cancer (NSCLC) were enrolled in this 2-part study. To identify the recommended phase 2 combination dose (RP2CD), Part 1 enrolled patients without restriction on prior therapy to evaluate escalating dose cohorts of amivantamab (700–1050 mg, iv once weekly for 28 days; biweekly thereafter) in combination with standard monotherapy dosing of lazertinib (240 mg oral daily). The ongoing Part 2 dose expansion Cohort E is evaluating preliminary efficacy, without biomarker selection, in patients progressing on osimertinib. Response was assessed by investigator per RECIST v1.1.

Results

As of 17 March 2020, 71 patients received the combination: median age was 61 y (36–79), median prior lines was 1 (0–9). In Part 1, the RP2CD was the maximally assessed doses of 1050 mg (1400 mg, ≥80 kg) amivantamab + 240 mg lazertinib. Interim safety profile includes rash (78%), infusion related reaction (61%), paronychia (42%), stomatitis (31%), pruritus (24%), and diarrhea (14%). Majority of treatment-related AEs were grade 1–2, with grade ≥3 reported in 7%. As of 30 April 2020, in 23 Part 1 patients with measurable disease, the overall response rate (ORR) was 43.5% (95% CI, 23.2–65.5) with 10 partial responses (PRs), and 9 patients with stable disease (SD); median treatment duration was 8.2 months (0.5–10.7), with 13 patients still ongoing. In the post-osimertinib expansion Cohort E, early antitumor activity is being observed in 14/20 response-evaluable patients with 1 complete response, 7 PRs (2 pending confirmation), and 6 SD with tumor shrinkage.

Conclusions

Amivantamab can be combined safely with lazertinib at their respective full monotherapy doses. Encouraging preliminary activity was observed in osimertinib-relapsed disease: updated data will be presented.

Clinical trial identification

NCT02609776; submitted November 18, 2015.

Editorial acknowledgement

Medical writing support was provided by Tracy T. Cao, PhD (Janssen Global Services, LLC) and funded by Janssen Global Services, LLC.

Legal entity responsible for the study

Janssen R&D.

Funding

Janssen R&D.

Disclosure

B.C. Cho: Advisory/Consultancy: Novartis, AstraZeneca, Boehringer Ingelheim, Roche, Bristol-Myers Squibb, Yuhan, Pfizer, Lilly, Janssen, Takeda, MSD, Ono Pharmaceuticals; Speaker Bureau/Expert testimony: Novartis; Licensing/Royalties: Champions Oncology; Shareholder/Stockholder/Stock options: Theravance, Gencurix, Bridgebio Therapeutics, Novartis, Bayer, AstraZeneca, Mogam Biotechnology Research Institute, Dong-A ST, Champions Oncology, Janssen, Yuhan, Ono Pharmaceutical, Dizal Pharma, MSD; Research grant/Funding (self): Novartis, Bayer, AstraZeneca, Mogam Biotechnology Research Institute, Dong-A ST, Champions Oncology, Janssen, Yuhan, Ono Pharmaceutical, Dizal Pharma, MSD. K.H. Lee: Advisory/Consultancy: Bristol-Myers Squibb, MSD, AstraZeneca; Honoraria (self): Bristol-Myers Squibb, MSD, AstraZeneca. D-W. Kim: Travel/Accommodation/Expenses: Daiichi Sankyo, Amgen; Research grant/Funding (institution): Alpha Biopharma, AstraZeneca/MedImmune, Hanmi, Janssen, Merus, Mirati Therapeutics, MSD, Novartis, Ono Pharmaceutical, Pfizer, Roche/Genentech, Takeda, TP Therapeutics, Xcovery, Yuhan, Boehringer Ingelheim. J-Y. Han: Advisory/Consultancy: MSD Oncology, AstraZeneca, Bristol-Myers Squibb, Lilly, Novartis, Takeda, Pfizer; Honoraria (self): Roche, AstraZeneca, Bristol-Myers Squibb, MSD, Takeda; Research grant/Funding (self): Roche, Pfizer, Ono Pharmaceutical, Takeda. A. Spira: Advisory/Consultancy, AstraZeneca/MedImmune consulting applies to my institution: Array BioPharma, Incyte, Amgen, Novartis, AstraZeneca/MedImmune; Shareholder/Stockholder/Stock options: Lilly; Honoraria (self): CytomX Therapeutics, AstraZeneca/MedImmune, Merck, Takeda, Amgen; Research grant/Funding (institution): Roche, AstraZeneca, Boehringer Ingelheim, Astellas Pharma, MedImmune, Novartis, Newlink Genetics, Incyte, AbbVie, Ignyta, LAM Therapeutics, Trovagene, Takeda, Macrogenics, CytomX Therapeutics, Astex Pharmaceuticals, Bristol-Myers Squibb, Loxo, Arch Therap; Research grant/Funding (self): LAM Therapeutics. E.B. Haura: Advisory/Consultancy: Janssen; Travel/Accommodation/Expenses: Bristol-Myers Squibb, Roche, Janssen; Research grant/Funding (institution): Janssen, Novartis, Revolution Medicines, AstraZeneca, Genentech; Research grant/Funding (self): FORMA Therapeutics, Incyte. J.K. Sabari: Advisory/Consultancy: AstraZeneca. R.E. Sanborn: Advisory/Consultancy: Amgen, Seattle Genetics, Peregrine Pharmaceuticals, ARIAD, Genentech/Roche, AstraZeneca, Celldex, AbbVie, Takeda; Travel/Accommodation/Expenses: Five Prime Therapeutics, Janssen, AstraZeneca; Honoraria (self): AstraZeneca; Research grant/Funding (institution): Bristol-Myers Squibb, MedImmune; Research grant/Funding (self): Merck. J.M. Bauml: Advisory/Consultancy: Bristol-Myers Squibb, Merck, AstraZeneca, Genentech, Celgene, Boehringer Ingelheim, Guardant Health, Takeda, Novartis, Janssen, Ayala Pharmaceuticals, Regeneron; Research grant/Funding (institution): Merck, Carevive Systems, Novartis, Incyte, Bayer, Janssen, AstraZeneca, Takeda, Amgen. J.E. Gomez: Speaker Bureau/Expert testimony: Bristol-Myers Squibb, Atara, AstraZeneca. P. Lorenzini, J.R. Infante, J. Xie, N. Haddish-Berhane, M. Thayu, R.E. Knoblauch: Full/Part-time employment: Janssen; Shareholder/Stockholder/Stock options: Johnson & Johnson. K. Park: Advisory/Consultancy: AstraZeneca, Boehringer Ingelheim, Lilly, Hanmi, Novartis, Ono Pharmaceutical, Roche, Bristol-Myers Squibb, MSD, Blueprint Medicines, Amgen, Merck KGaA, Loxo, AbbVie, Daiichi Sankyo; Speaker Bureau/Expert testimony: Boehringer Ingelheim, AZD; Research grant/Funding (self): AstraZeneca, MSD Oncology. All other authors have declared no conflicts of interest.

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Proffered Paper - NSCLC metastatic 1 Proffered Paper session

Invited Discussant 1257O and 1258O

Lecture Time
14:49 - 14:59
Speakers
  • Colin Lindsay (Manchester, United Kingdom)
Room
Channel 1
Date
20.09.2020
Time
14:25 - 16:05
Proffered Paper - NSCLC metastatic 1 Proffered Paper session

Q&A and live discussion

Lecture Time
14:59 - 15:09
Speakers
  • Lecia V. Sequist (Boston, MA, United States of America)
Room
Channel 1
Date
20.09.2020
Time
14:25 - 16:05
Proffered Paper - NSCLC metastatic 1 Proffered Paper session

LBA50 - ACTIVE: Apatinib plus gefitinib versus placebo plus gefitinib as first-line treatment for advanced epidermal growth factor receptor-mutant (EGFRm) non-small-cell lung cancer (NSCLC): A multicentered, randomized, double-blind, placebo-controlled phase III trial (CTONG1706)

Presentation Number
LBA50
Lecture Time
15:09 - 15:21
Speakers
  • Li Zhang (Guangzhou, China)
Room
Channel 1
Date
20.09.2020
Time
14:25 - 16:05

Abstract

Background

Blocking vascular endothelial growth factor receptor (VEGFR) pathway can enhance the efficacy of EGFR-TKI in EGFRm NSCLC. ACTIVE is the first phase III study evaluating apatinib, an oral small molecule VEGFR2-TKI, or placebo plus gefitinib as first-line therapy in patients (pts) with EGFRm NSCLC.

Methods

Treatment-naïve pts with classic EGFR mutation (ex19del or L858R) were randomized (1:1) to receive once-daily oral apatinib 500 mg plus gefitinib 250 mg (AG arm) or placebo plus gefitinib 250 mg (G arm). Stratification factors: EGFR mutation type (ex19del, L858R), sex, and performance status (0, 1). The primary endpoint was PFS (RECIST 1.1) assessed by blinded independent radiology review committee (IRRC). Secondary endpoints: PFS by investigator (INV), OS, ORR, DCR, DOR, TTPD, QoL and safety. Next-generation sequencing (NGS) was used to analyze baseline and post-progression samples for exploring efficacy predictors and acquired resistance.

Results

313 pts were enrolled (AG arm, n=157; G arm, n=156). Median follow-up was 15.8 months (IQR 12.6, 20.4). Median PFS by IRCC was 13.7 versus 10.2 months in AG and G arms (HR = 0.71, 95% CI 0.54-0.95; p = 0.0189). Prolonged PFS by INV (HR = 0.71, 95% CI 0.53-0.95) was observed. OS data are immature at cutoff (29.4% events). ORR was 77.1% and 73.7% in AG and G arms (p = 0.5572). Pts with ex19del had better HR than L858R (HR = 0.67, 0.45-0.99; 0.72, 0.48-1.09). NGS results of baseline samples showed a marginally significant improved PFS in TP53-mutant disease. Pts with TP53 exon 8 mutation significantly benefited from dual blockade (HR = 0.24, 0.06-0.91). Grade 3-4 adverse events (AEs) of the two arms were similar, except increased risk of hypertension and proteinuria (46.5%; 17.8%) in AG arm. No AEs beyond expectation were reported. Other endpoints and NGS results for resistance will be presented onsite.

Conclusions

Apatinib plus gefitinib as first-line therapy demonstrated superior PFS. TP53 exon 8 mutation status could serve as an efficacy predictor. Safety profiles were consistent with that of the individual drugs and acceptable.

Clinical trial identification

NCT02824458.

Legal entity responsible for the study

Sun Yat-sen University Cancer Center.

Funding

The 5010 Clinical Research Foundation of Sun Yat-sen University; Jiangsu Hengrui Medicine Co., Ltd.

Disclosure

All authors have declared no conflicts of interest.

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Proffered Paper - NSCLC metastatic 1 Proffered Paper session

1259O - A randomized phase II study of osimertinib with or without bevacizumab in advanced lung adenocarcinoma patients with EGFR T790M mutation (West Japan Oncology Group 8715L)

Presentation Number
1259O
Lecture Time
15:21 - 15:33
Speakers
  • Yukihiro Toi (Sendai, Japan)
Room
Channel 1
Date
20.09.2020
Time
14:25 - 16:05

Abstract

Background

Although several studies demonstrated that EGFR-TKI plus anti-angiogenic therapy would be a promising treatment strategy in EGFR-mutated lung adenocarcinoma patients, these evidences were from the first-generation EGFR-TKI. Preclinical study showed the potential of this combination in EGFR T790M mutated model. Thus, to explore the efficacy and safety of osimertinib (Osi) in combination with bevacizumab (Bv) among advanced lung adenocarcinoma patients with EGFR T790M mutation is intriguing.

Methods

Advanced lung adenocarcinoma patients who progressed with prior EGFR-TKI (other than third generation TKI) and acquired EGFR T790M mutation were randomized to Osi (80mg, p.o., everyday) or Osi+Bv (15mg/kg, div, every 3 weeks) in a 1:1 ratio. Primary endpoint was progression-free survival (PFS). Secondary endpoints consisted of overall response rate (ORR), time to treatment failure (TTF), overall survival (OS) and safety (Trial Identifier, UMIN000023761). Based on the hypothesis that Osi+Bv will provide a 0.55 improvement in PFS over Osi alone with median PFS of 9 months, the planned sample size was 80 to provide a power of 80% at two-sided significance level of 20%.

Results

Between Aug 2017 and Sep 2018, 81 patients were randomized (41 in Osi and 40 in Osi+Bv). Of those, median age was 68 (range, 41-82); male, 41%; c-stage III/IV/recurrence, 7/70/22%; PS 0/1, 46/54%; with brain metastasis, 26%; prior history of cytotoxic chemotherapy; 21%. Baseline characteristics were similar between the arms. Although ORR was better in Osi+Bv than Osi (68 % vs 54%), median PFS was shorter in Osi+Bv (9.4 months vs 13.5 months, HR 1.44 [95%CI, 1.00-2.08], p = 0.20). Median TTF was also shorter in Osi+Bv (8.4 months vs 11.2 months, HR 1.54, p = 0.12) and OS was similar (median not reached vs 22.1 months, p = 0.96). In Osi+Bv arm, common adverse events ≥Gr 3 were proteinuria (23%), hypertension (20%) and infection (10%).

Conclusions

Compared with Osi, Osi+Bv failed to show prolongation of PFS in advanced lung adenocarcinoma patients with EGFR T790M mutation.

Clinical trial identification

UMIN000023761.

Legal entity responsible for the study

West Japan Oncology Group.

Funding

AstraZeneca K.K.

Disclosure

Y. Toi: Honoraria (self): AstraZeneca; Honoraria (self): Bristol-Myers Squibb; Honoraria (self): MSD; Honoraria (self): Ono Pharmaceutical. H. Hayashi: Honoraria (self), Research grant/Funding (self): AstraZeneca K.K.; Honoraria (self), Research grant/Funding (self): Boehringer Ingelheim Japan Inc.; Honoraria (self): Bristol-Myers Squibb Co. Ltd.; Honoraria (self): Chugai Pharmaceutical Co. Ltd.; Honoraria (self): Eli Lilly Japan K.K.; Honoraria (self): MSD K.K.; Honoraria (self), Research grant/Funding (self): Ono Pharmaceutical Co. Ltd.; Honoraria (self): Pfizer Japan Inc.; Honoraria (self): Shanghai Haihe Biopharm; Honoraria (self): Kyorin pharmaceutical co. ltd; Honoraria (self): Novartis Pharma K.K. ; Honoraria (self): Taiho Pharmaceutical Co. Ltd. D. Fujimoto: Honoraria (self), Research grant/Funding (self): AstraZeneca; Honoraria (self): Boehringer Ingelheim; Honoraria (self): Bristol-Myers Squibb; Honoraria (self): Chugai Pharmaceutical; Honoraria (self): Eli Lilly; Honoraria (self): MSD; Honoraria (self): Novartis; Honoraria (self): Ono Pharmaceutical; Honoraria (self): Taiho Pharmaceutical. M. Tachihara: Honoraria (self), Research grant/Funding (self): AstraZeneca; Honoraria (self): Boehringer Ingelheim,; Honoraria (self): Chugai Pharmaceutical; Honoraria (self): Eli Lilly; Honoraria (self): MSD; Honoraria (self): Olympus; Honoraria (self): Ono Pharmaceutical; Honoraria (self): Taiho Pharmaceutical. N. Furuya: Honoraria (self): AstraZeneca; Honoraria (self): Boehringer Ingelheim; Honoraria (self): Bristol-Myers Squibb; Honoraria (self): Chugai Pharmaceutical; Honoraria (self): Eli Lilly; Honoraria (self): Kyowa Kirin; Honoraria (self): MSD; Honoraria (self): Novartis; Honoraria (self): Ono Pharmaceutical; Honoraria (self): Taiho Pharmaceutical. J. Shimizu: Honoraria (self): AstraZeneca; Honoraria (self): MSD; Honoraria (self): Ono Pharmaceutical; Honoraria (self): Taiho Pharmaceutical; Honoraria (self): Chugai Pharmaceutical. N. Katakami: Honoraria (self): AstraZeneca; Honoraria (self): Boehringer Ingelheim; Honoraria (self): Bristol-Myers Squibb; Honoraria (self): Chugai Pharmaceutical; Honoraria (self): Eli Lilly; Honoraria (self): MSD; Honoraria (self): Novartis; Honoraria (self): Ono Pharmaceutical; Honoraria (self): Taiho Pharmaceutical; Honoraria (self): Japan Pharmaceutical Association. K. Azuma: Honoraria (self): AstraZeneca; Honoraria (self): Bristol-Myers Squibb; Honoraria (self): Chugai Pharmaceutical; Honoraria (self): MSD; Honoraria (self): Novartis; Honoraria (self): Ono Pharmaceutical. N. Miura: Honoraria (self): Nippon Boehringer Ingelheim Co., Ltd,; Honoraria (self): Ono Pharmaceutical Co. Ltd; Honoraria (self): Taiho Pharmaceutical Co., Ltd. K. Nishino: Honoraria (self): AstraZeneca; Honoraria (self): Boehringer Ingelheim; Honoraria (self): Bristol-Myers Squibb; Honoraria (self): Chugai Pharmaceutical; Honoraria (self): Eli Lilly; Honoraria (self): F. Hoffmann-La Roche Ltd; Honoraria (self): Novartis; Honoraria (self): Ono Pharmaceutical; Honoraria (self): Pfizer. S. Teraoka: Honoraria (self): AstraZeneca; Honoraria (self): Chugai Pharmaceutical; Honoraria (self): Novartis; Honoraria (self): Boehringer Ingelheim; Honoraria (self): Taiho Pharmaceutical; Honoraria (self): Ono Pharmaceutical Co.,Ltd. S. Morita: Honoraria (self): AstraZeneca K.K.; Honoraria (self): Bristol-Myers Squibb Company; Honoraria (self): Chugai Pharmaceutical Co. Ltd.; Honoraria (self): Eli Lilly Japan K.K.; Honoraria (self): MSD K.K.; Honoraria (self), Research grant/Funding (self): Nippon Boehringer Ingelheim Co. Ltd.; Honoraria (self): Ono Pharmaceutical Co. Ltd.; Honoraria (self): Pfizer Japan Inc.; Honoraria (self): Taiho Pharmaceutical Co. Ltd. K. Nakagawa: Honoraria (self), Research grant/Funding (self): AstraZeneca K.K.; Honoraria (self): Nichi-Iko Pharmaceutical Co., Ltd.; Honoraria (self), Research grant/Funding (self): Astellas Pharma Inc.; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Takeda Pharmaceutical Co.,Ltd.; Honoraria (self), Research grant/Funding (self): MSD K.K.; Honoraria (self), Research grant/Funding (self): Taiho Pharmaceutical Co.,Ltd.; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Ono Pharmaceutical Co.,Ltd.; Honoraria (self), Research grant/Funding (self): Bristol-Myers Squibb Company; Honoraria (self), Research grant/Funding (self): Nippon Boehringer Ingelheim Co.,Ltd.; Honoraria (self), Research grant/Funding (self): Eli Lilly Japan K.K.; Honoraria (self), Research grant/Funding (self): Novartis Pharma K.K.; Honoraria (self): SymBio Pharmaceuticals Limited.; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Pfizer Japan Inc.; Honoraria (self), Research grant/Funding (self): Chugai Pharmaceutical Co.,Ltd.; Honoraria (self), Research grant/Funding (self): Daiichi Sankyo Co., Ltd.; Honoraria (self), Advisory/Consultancy: KYORIN Pharmaceutical Co.,Ltd.; Honoraria (self): Thermo Fisher Scientific K.K.; Honoraria (self): Roche Diagnostics K.K.; Honoraria (self): Nippon Kayaku Co.,Ltd.; Honoraria (self), Research grant/Funding (self): Bayer Yakuhin, Ltd; Honoraria (self), Research grant/Funding (self): Merck Biopharma Co., Ltd.; Honoraria (self), Research grant/Funding (self): AbbVie Inc.; Research grant/Funding (self): Kissei Pharmaceutical Co.,Ltd.; Research grant/Funding (self): Kyowa Hakko Kirin Co.,Ltd; Research grant/Funding (self): Otsuka Pharmaceutical Co., Ltd. N. Yamamoto: Honoraria (self), Research grant/Funding (self): AstraZeneca K.K.; Honoraria (self), Research grant/Funding (self): Boehringer Ingelheim; Honoraria (self), Research grant/Funding (self): Chugai Pharmaceutical; Honoraria (self), Research grant/Funding (self): Eli Lilly; Honoraria (self), Research grant/Funding (self): MSD; Honoraria (self): Novartis; Honoraria (self), Research grant/Funding (self): Ono Pharmaceutical Co.,Ltd.; Honoraria (self), Research grant/Funding (self): Pfizer; Research grant/Funding (self): Astellas Pharma Inc; Research grant/Funding (self): Bristol-Myers Squibb; Research grant/Funding (self): Daiichi Sankyo; Research grant/Funding (self): Takeda Pharmaceutical; Research grant/Funding (self): Taiho Pharmaceutical; Research grant/Funding (self): Terumo Corporation; Research grant/Funding (self): Toppan Printing Co., Ltd. All other authors have declared no conflicts of interest.

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Proffered Paper - NSCLC metastatic 1 Proffered Paper session

Invited Discussant LBA50 and 1259O

Lecture Time
15:33 - 15:43
Speakers
  • Lecia V. Sequist (Boston, MA, United States of America)
Room
Channel 1
Date
20.09.2020
Time
14:25 - 16:05
Proffered Paper - NSCLC metastatic 1 Proffered Paper session

Q&A and live discussion

Lecture Time
15:43 - 15:53
Speakers
  • Lecia V. Sequist (Boston, MA, United States of America)
Room
Channel 1
Date
20.09.2020
Time
14:25 - 16:05