Startseite Kongressberichte 2019 Annual Meeting of the American Society of Clinical Oncology 2019 Lung Cancer

Choice of Oral & Poster Presentations

See video statement Sacha Rothschild at the bottom of the page discussing the first 9 studies mentioned below:

Edward B. Garon, Matthew David Hellmann, Enric Carcereny Costa, Natasha B. Leighl, et al.

Five-year long-term overall survival for patients with advanced NSCLC treated with pembrolizumab: Results from KEYNOTE-001. | 2019 ASCO Annual Meeting Abstracts

Conclusions: In KEYNOTE-001, 5-y OS rate was 23.2% in treatment-naive pts and 15.5% in previously treated pts with advanced NSCLC treated with pembro, compared to a historical rate of ~5% (per SEER 2008–2014), prior to the introduction of anti–PD-1 therapy. 5-y OS rate was at least 25% in pts with PD-L1 TPS ≥50% in both pt populations in KEYNOTE-001. Clinical trial information: NCT01295827

OS by PD-L1 TPS.
  n Median OS (95% CI), mo 36-mo OS rate, % 60-mo OS rate, %
Treatment-naive 101* 22.3 (17.1‒32.3) 37.0 23.2
- TPS ≥50% 27 35.4 (20.3‒63.5) 48.1 29.6
- TPS 1%–49% 52 19.5 (10.7‒26.3) 27.5 15.7
Previously treated 449† 10.5 (8.6‒13.2) 20.9 15.5
- TPS ≥50% 138 15.4 (10.6‒18.8) 30.4 25.0
- TPS 1%–49% 168 8.5 (6.0‒12.6) 16.9 12.6
- TPS <1% 90 8.6 (5.5–10.6) 11.1 3.5

*PD-L1 TPS was <1% in 12 pts (data not reported due to small pt numbers) and was unknown in 10 pts. †PD-L1 TPS was unknown in 53 pts.

 

Shirish M. Gadgeel, Marina Chiara Garassino, Emilio Esteban, Giovanna Speranza, et al.

KEYNOTE-189: Updated OS and progression after the next line of therapy (PFS2) with pembrolizumab (pembro) plus chemo with pemetrexed and platinum vs placebo plus chemo for metastatic nonsquamous NSCLC.

Conclusions: 1L pembro + pemetrexed/platinum continued to show substantial OS benefit in metastatic nonsquamous NSCLC, regardless of PD-L1 TPS and despite 54% of pts in the placebo + chemo arm receiving subsequent immunotherapy. Median OS, PFS and PFS2 were approximately doubled with pembro + chemo. These data confirm that pembro should be given as part of 1L therapy to maximize outcomes in both PD-L1?expressing and PD-L1?non-expressing NSCLC. Clinical trial information: NCT02578680

 

Tina Cascone, William Nassib William, Annikka Weissferdt, Heather Y. Lin, et al.

Neoadjuvant nivolumab (N) or nivolumab plus ipilimumab (NI) for resectable non-small cell lung cancer (NSCLC): Clinical and correlative results from the NEOSTAR study.

Conclusions: Overall a 24% MPR rate to neoadjuvant ICIs was observed. NI induced a higher % of non-viable tumor and of tissue resident memory TILs vs N. Antitumor activity was associated with higher pre-treatment PD-L1 levels. Clinical trial information: NCT03158129
 
Mariano Provencio, Ernest Nadal, Amelia Insa, Rosario Garcia-Campelo, et al.
Conclusions: This is the first multicentric study to CT-IO in the neoadjuvant setting in stage IIIA. Neoadjuvant CT-IO with nivolumab in resectable IIIA NSCLC yields a high complete pathologic response rate that has never been seen previously and unsuspected by RECIST criteria. Preliminary correlative analyses in blood samples are included in a separate abstract. EudraCT Number: 2016-003732-20. Clinical trial information: NCT 03081689.
 
SAKK 16/14 - Phase-II-Studie zur Zugabe einer neoadjuvanten Immuntherapie:
(NCT02572843)


Juergen Wolf, Takashi Seto, Ji-Youn Han, Noemi Reguart, et al.

Capmatinib (INC280) in METΔex14-mutated advanced non-small cell lung cancer (NSCLC): Efficacy data from the phase II GEOMETRY mono-1 study.

Conclusions: These data confirm capmatinib to be a promising new treatment option for pts with METΔex14-mutated advanced NSCLC regardless of the line of therapy with deep and durable responses and manageable toxicity profile. Clinical trial information: NCT02414139

 

Paul K. Paik, Remi Veillon, Alexis B. Cortot, Enriqueta Felip, et al.

Phase II study of tepotinib in NSCLC patients with METex14 mutations.

Conclusions: Tepotinib has promising activity with a long DoR across treatment lines in NSCLC pts with METex14 mutations detected by LBx or TBx. The safety profile was favorable. Recruitment is ongoing. Clinical trial information: NCT02864992

Responders/Evaluable pts (%) [95% CI] LBx
 TBx
IRC INV IRC INV
ORR Line of therapy        
1L 8/12 (66.7) 11/12 (91.7) 6/16 (37.5) 8/15 (53.3)
  [34.9, 90.1] [61.5, 99.8] [15.2, 64.6] [26.6, 78.7]
2L 6/11 (54.5) 7/12 (58.3) 6/12 (50.0) 9/13 (69.2)
  [23.4, 83.3] [27.7, 84.8] [21.1, 78.9] [38.6, 90.9]
≥3L 4/12 (33.3) 5/12 (41.7) 5/13 (38.5) 7/13 (53.8)
  [9.9, 65.1] [15.2, 72.3] [13.9, 68.4] [25.1, 80.8]
Overall ORR 18/35 (51.4) 23/36 (63.9) 17/41 (41.5) 24/41 (58.5)
  [34.0, 68.6] [46.2, 79.2] [26.3, 57.9] [42.1, 73.7]
mDoR, months (range) 9.8 (1.1, 18.0) 17.1 (1.3, 21.5) 12.4 (1.1, 18.0) 14.3 (1.3, 21.5)

 

Justin F. Gainor, Dae Ho Lee, Giuseppe Curigliano, Robert Charles Doebele, et al.

Conclusions: BLU-667 demonstrated potent, durable and broad antitumor activity and was well tolerated in pts with advanced RET-fusion+ NSCLC. Enrollment of the expansion is ongoing with registrational intent. Clinical trial information: NCT03037385

 

Guanghui Gao, Xingya Li, Qiming Wang, Yiping Zhang, et al.

Single-arm, phase II study of pyrotinib in advanced non-small cell lung cancer (NSCLC) patients with HER2 exon 20 mutation.

Conclusions: Pyrotinib as a single agent demonstrated promising anti-tumor activity and acceptable safety profile in heavily pretreated HER2 mutant NSCLC patients. Clinical trial information: NCT02834936

 

Luis G. Paz-Ares, David R. Spigel, Christoph Zielinski, Yuanbin Chen, et al.

RESILIENT: Study of irinotecan liposome injection (nal-IRI) in patients with small cell lung cancer—Preliminary findings from part 1 dose-defining phase.

Conclusions: Initial assessment suggests that nal-IRI at 70 mg/m2 dose given bi-weekly is well-tolerated and has promising antitumor activity in patients with SCLC who progressed on or after platinum regimen. Part 1 dose expansion is ongoing. Clinical trial information: NCTN03088813.

Best Objective Response (BOR).
Best Objective Response (BOR) Nal-IRI 85 mg/m2
(n=4)		 Nal-IRI 70 mg/m2
(n=8)		 Nal-IRI Overall doses (N=12)
Complete response (CR) 0 0 0
Partial response (PR) 1 (25%) 3 (37.5%) 4 (33.3)
Stable disease (SD) 1 (25%) 2 (25%) 3 (25%)
Progressive disease (PD) 1 (25%) 1 (12.5%) 2 (16.7%)
Non-evaluable 1 (25%) 2 (25%) 3 (25%)

 

Mairead Geraldine McNamara, Jayne Swain, Zoe Craig, Jonathan Wadsley, et al.

NET-02: A multi-center, randomised, phase II trial of liposomal irinotecan (nal-IRI) and 5-fluorouracil (5-FU)/folinic acid or docetaxel as second-line therapy in patients (pts) with progressive poorly differentiated extra-pulmonary neuroendocrine carcinoma (PD-EP-NEC).

Methods: This is a multi-centre, randomised, phase II trial of nal-IRI; 80mg/m2 intravenously (IV) over 90 mins, prior to 5-FU; 2400 mg/m2 infusion over 46 hrs and folinic acid, Q14 days, or docetaxel; 75mg/m2 IV over 60 mins, Q21 days, as second-line therapy in pts with progressive PD-EP-NEC (Ki-67 > 20%), with the overall aim of selecting a treatment for continuation to a phase III trial. The standard arm is that used in high-grade lung NEC, of which docetaxel is a second-line therapy option (NCCN guidelines) and combination regimens such as Irinotecan/5-FU are a second-line therapy option currently used without trial evidence for this subset of pts. Pts must have had prior treatment with first-line platinum-based chemotherapy, have documented disease progression and have an ECOG performance status of ≤2. This study plans to recruit 102 pts from 16 UK centres (over 37 mths). Primary endpoint is 6-mth progression-free survival (PFS) rate; trial is designed to have an 80% chance of demonstrating that the one-sided 95% confidence interval of the 6 mth PFS rate excludes 15%, if the true rate is at least 30%, where 30% is the required level of efficacy, and a rate of < 15% would give grounds for rejection. If both treatment arms exceed the required level of efficacy to warrant further evaluation in a phase III trial, treatment with the higher PFS rate at 6 mths will be selected. Secondary endpoints include overall survival, objective response rate, toxicity, quality of life, serum neuron-specific enolase. Exploratory endpoints include quantification of circulating tumour cells (CTCs), circulating tumour deoxyribonucleic acid (ctDNA) and molecular profiling of CTCs, ctDNA and tumour tissue, and generation of CTC-derived xenografts. This trial is open and has enrolled 6 pts at time of submission. Clinical trial information: 10996604.

 

 

Statement PD Dr. med. Dr. phil. Sacha Rothschild:

Lungentumore, wichtige Ergebnisse vom ASCO 2019: