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.
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
|n||Median OS (95% CI), mo||36-mo OS rate, %||60-mo OS rate, %|
|- 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.
Juergen Wolf, Takashi Seto, Ji-Youn Han, Noemi Reguart, et al.
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.
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
|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.
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.
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)||Nal-IRI 85 mg/m2
|Nal-IRI 70 mg/m2
|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: