bluuebunny/crossref_metadata_2025_split huggingface dataset:
MORPHEUS-EC: A phase Ib/II open-label, randomized study of first-line tiragolumab (tira) + atezolizumab (atezo) + chemotherapy (CT) in patients (pts) with esophageal cancer (EC).
Authors: Sun Jong-Mu , Chao Yee , Kim Sung-Bae , Rha Sun Young , Evans T.R. Jeffry , Strickland Andrew , Wainberg Zev A. , Chau Ian , Pelles-Avraham Sharon , Ajani Jaffer A. , Malhotra Ritu , Liu Qingyuan , Li Sijing , Cha Edward , Rahalkar Swapna , Allen Simon , Hsu Chih-Hung 
Published: January 2024

324 Background: TIGIT is a novel inhibitory immune checkpoint on activated T cells and NK cells. Tira (anti-TIGIT) may synergize with other immunotherapies, e.g. PD-L1/PD-1 inhibitors. The MORPHEUS platform comprises multiple phase Ib/II trials to identify early efficacy signals and safety of treatment (tx) combinations across cancers. We report interim data from MORPHEUS-EC (NCT03281369) evaluating the combination of tira + atezo with CT in pts with untreated locally advanced unresectable or metastatic EC. Methods: Eligible pts (locally advanced unresectable, or metastatic EC with no prior systemic treatment; ECOG PS 0–1) were randomized to receive: cisplatin 80mg/m2 + 5-FU 800mg/m2/24 hours on Days 1–5 of each cycle (CT); atezo 1200mg + cisplatin + 5-FU (atezo + CT); or tira 600mg + atezo + cisplatin + 5-FU (tira + atezo + CT) in 21-day cycles. Primary endpoint: investigator (INV)-assessed objective response rate (ORR). Key secondary endpoints: INV-assessed progression-free survival (PFS), overall survival (OS), safety. Results: 152 pts were randomized to: CT (n=24; control); atezo + CT (n=65) or tira + atezo + CT (n=63). As of 14 Mar 2023, median follow-up was 8.7 months (mo) in the CT arm, 11.4 mo in the atezo + CT arm and 10.9 mo in the tira + atezo + CT arm. Pt characteristics were generally balanced between arms. ORR was 47.8% (CT) vs 53.8% (atezo + CT) vs 67.7% (tira + atezo + CT). Median PFS was 4.1 mo (CT) vs 6.8 mo (atezo + CT) vs 6.9 mo (tira + atezo + CT) (Table). ORR and PFS benefit was generally consistent across all pre-specified subgroups, including PD-L1 status. There was a numerical improvement in OS with tira + atezo + CT vs atezo + CT and CT alone (Table). Grade 3–5 adverse events (AEs) were 82.6% vs 83.1% vs 85.5% and treatment-related Grade 4/5 AEs were 4.3% vs 7.7% vs 14.5% for CT vs atezo + CT vs tira + atezo + CT. AEs leading to any tx discontinuation were 21.7%, 16.9% and 35.5%, respectively. Conclusions: Clinically meaningful improvements in INV-assessed ORR and PFS and a trend of improved OS were observed with tira + atezo + CT when compared with CT and atezo + CT. These results support the contribution of both tira and atezo in combination with CT. The safety profile was consistent with the known risks of the individual tx. Clinical trial information: NCT03281369 . [Table: see text]
Survival outcomes in patients with resectable gastric cancer treated with total neoadjuvant therapy.
Authors: Song Yun , Hirata Yuki , Ajani Jaffer A. , Blum Murphy Mariela A. , Li Jenny Jing , Das Prajnan , Minsky Bruce D. , Mansfield Paul F. , Ikoma Naruhiko , Badgwell Brian D. 
Published: January 2024

338 Background: Perioperative chemotherapy is the standard of care for patients diagnosed with advanced gastric cancer. However, the use of total neoadjuvant therapy (TNT), which includes both chemotherapy and chemoradiation, is increasing in other malignancies. The purpose of this study is to determine overall survival (OS) in a contemporary cohort of gastric cancer patients treated with TNT and surgical resection. Methods: Patients diagnosed with microsatellite-stable clinical T2+ or N+ gastric adenocarcinoma (January 2012 to June 2022) were identified from a prospectively maintained institutional database. Those who underwent staging laparoscopy and received neoadjuvant chemotherapy and chemoradiation therapy, followed by gastrectomy, were included in the study. OS and variables associated with OS were determined using standard statistical methods. Results: Of 203 study patients, the median (interquartile range) age was 61 (50-69.5) years and 50 (24.6%) had tumor involving the gastroesophageal junction. The most common TNT sequence was chemotherapy followed by chemoradiation, which was utilized in 173 (85.2%) patients. The chemotherapy regimen typically given was fluorouracil and oxaliplatin in 149 (73.4%) patients. The most common radiation dose was 45 Gy in 25 fractions (169 [83.3%] patients), with 18 (8.9%) patients receiving 30 Gy in 10 fractions. One hundred ninety-seven (97.0%) patients completed all their planned neoadjuvant therapy. Surgical resection included total gastrectomy in 108 (53.2%), adjacent organ resection in 24 (11.8%), and extended (D1+/D2) lymphadenectomy in 193 (95.1%) patients. Pathologic complete response was achieved (pCR) in 32 (15.8%) patients. The median OS was 8.4 (95% confidence interval [CI] 6.5-not reached) years, and the 5-year OS rate was 65.2% (95% CI 57.8-73.5%). Patients with pCR had a 5-year OS rate of 89.1% (95% CI 78.1-100.0%). On multivariable analysis, D1+/D2 lymphadenectomy (HR 0.21 [95% CI 0.088-0.51]), post-treatment pathologic (yp) T (ypT3 vs ypT0, HR 3.11 [95% CI 1.09-8.82]; ypT4 vs ypT0, HR 5.51 [95% CI 1.64-18.5]) and N stages (ypN1 vs ypN0, HR 2.41 [95% CI 1.13-5.13]; ypN2 vs ypN0, HR 2.43 [95% CI 1.14-5.20]; ypN3 vs ypN0, HR 4.70 [95% CI 2.09-10.6]), incidental distant metastasis at time of resection (HR 3.75 [95% CI 1.50-9.37]), and postoperative complications (HR 2.06 [95% CI 1.21-3.52]) were associated with OS. Conclusions: TNT is associated with a high rate of treatment completion and promising long-term OS for patients with resectable gastric cancer. Comparative studies with perioperative treatment and predictors of tumor response will be important in identifying patients suitable for TNT.
Prophylactic para-aortic lymph node dissection after neoadjuvant chemotherapy for gastric cancer with bulky lymph node metastasis.
Authors: Kenichiro Furukawa , Matsumoto Yosuke , Soneda Wataru , Koseki Yusuke , Fujiya Keiichi , Tanizawa Yutaka , Bando Etsuro 
Published: January 2024

344 Background: Neoadjuvant chemotherapy (NAC) followed by D2 gastrectomy with para-aortic lymph node dissection (PAND) is the standard treatment for gastric cancer with extensive lymph node metastasis (ELM) in Japan. ELM includes bulky lymph node metastasis along the celiac artery and its branches (Bulky N2) and metastasis of para-aortic lymph nodes (PAN). However, the benefit of PAND for gastric cancer with Bulky N2 but without PAN involvement is unclear. The aim of this study was to evaluate the efficacy of prophylactic PAND after NAC for this subgroup of patients. Methods: We retrospectively reviewed 21 patients who underwent NAC followed by curative (R0) gastrectomy for Bulky N2 (+) but PAN (-) gastric cancer from 2008 to 2019. Bulky lymph node was defined as one lymph nodes ≥ 3cm or two adjacent lymph nodes ≥ 1.5cm each. PAN metastasis included no. 16a2/16b1 lymph node metastasis. PAND was defined as systematic lymph node dissection of PAN. Patients were divided into two groups: a D2+PAND group (11 patients) and a D2 group (10 patients). We compared the clinicopathological features, recurrence patterns, and survival outcomes between the two groups. Results: The most common NAC regimen was S-1+cisplatin (12 patients: 57%), and other regimens in D2+PAND group included docetaxel+S-1+cisplatin or oxaliplatin. The D2+PAND group had longer operation time (p=0.006), and tended toward more undifferentiated histological type (p=0.063), better pathological response (p=0.086), and higher rate of adjuvant chemotherapy (p=0.090) than the D2 group. The ypStage was similar between the two groups. Pathological PAN metastasis was detected in two patients (18%) in D2+PAND group. Recurrence occurred in seven (70%) patients in D2 group and three (27%) patients in D2+PAND group, and lymph node recurrence was observed in four (40%), and one (10%) patients, respectively. The D2+PAND group had significantly better overall survival, recurrence-free survival, and disease-specific survival than the D2 group (p=0.008, 0.008, and 0.020, respectively). Conclusions: Prophylactic PAND after NAC may reduce recurrence risk for locally advanced gastric cancer with Bulky N2 but without PAN involvement.
Safety and efficacy of nanosomal docetaxel lipid suspension (NDLS) in patients with advanced gastric adenocarcinoma.
Authors: Ostwal Vikas S. , SHARMA ATUL , Ghosh Joydeep , Reddy Rakesh , K Lakshmi Priyadarshini , Srinivas B. J. , Raghu Raman Ramaiyer , Kota Rajesh , Panda Soumya Surath , Agarwal Amit , Seshachalam Arun , Nemade Bhushan Tapiram , Ahmad Ateeq , Sheikh Saifuddin , Ali Shoukath M , Paithankar Mahesh , Patel Lav , Rajani Anil , Bunger Deepak , Ahmad Imran 
Published: January 2024

348 Background: Nanosomal docetaxel lipid suspension (NDLS) was developed to overcome toxicity issues associated with conventional docetaxel. Docetaxel, cisplatin, 5-fluorouracil (5-FU; DCF) or modified DCF (mDCF) is one of the recommended first-line regimens for patients with metastatic gastric adenocarcinoma (GAC). However, majority of the patients experienced grade 3/4 toxicities with DCF regimen using conventional docetaxel. The present study evaluated the safety and efficacy of NDLS-based mDCF/DCF regimens in patients with metastatic GAC. Methods: In this multicentric, open-label, clinical trial, patients with previously untreated metastatic GAC were enrolled. Patients received either mDCF [NDLS 40 mg/m2 on day 1 (D1), C 40 mg/m2 on D2 or D3, 5-FU 400 mg/m2 bolus on D1, leucovorin 400 mg/m2 on D1, 5-FU 1000 mg/m2/day continuous infusion D1 & 2; q2w] for 9 cycles, or DCF [NDLS 75 mg/m2 on D1, C 75 mg/m2 on D1, 5-FU 750 mg/m2/day for 5 days given as continuous infusion; q3w] for 6 cycles. Prophylactic GCSF (Granulocyte Colony Stimulating Factor)/Peg-GCSF support was allowed in all patients. The primary endpoint was overall response rate (ORR) at week 18. Secondary endpoints were disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and safety outcomes. Patients were followed up to 1 year. Results: Fifty-two patients were enrolled, with mean (±SD) age of 52 (±9.6) years & male:female ratio of 32:20. Thirty-eight patients qualified for modified intent-to-treat (mITT) analysis for efficacy evaluation (mDCF: 33; DCF:5). At week 18, ORR was 57.9% & DCR was 81.6% in mITT population. In the per-protocol population (n=26), ORR was 61.5% at 18 weeks (mDCF:63.6%; DCF:50%). Safety set included all 52 patients. Any grade adverse events (AEs) were reported in 90.4% (n=47) of the patients; with 40.4% experiencing grade 3/4 AEs. All-grade AEs reported in ≥10% of the patients included anemia, neutropenia, abdominal pain, diarrhea, nausea, vomiting, fatigue, mucositis, decreased appetite, peripheral neuropathy; with majority of AEs being grade 1/2. Most common grade 3/4 AE was neutropenia; observed in 17.3% (n=9) patients (mDCF: 14%; DCF: 33.3%). Conclusions: NDLS-based regimens demonstrated efficacy & improved safety profile in the treatment of metastatic GAC. Clinical trial information: CTRI/2018/01/011450 . [Table: see text]
Evaluation of the efficacy and safety of a 3-weekly TS-1 regimen as adjuvant therapy for stage II and III advanced gastric cancer: A pilot study.
Authors: Bae Jihong , Sym Sun Jin , Park Joo-Hwan , Kim Young Saing , Ahn Hee Kyung , CHO EUN KYUNG , Shin Dong Bok , Park Ji-Hyeon , Yang Jun-Young , Lee Woon-Kee 
Published: January 2024

350 Background: Adjuvant therapy for stage II and III advanced gastric cancer (AGC) is essential in improving patient outcomes. The standard therapy, TS-1 at 80 mg/m2/day for 4 weeks with a 2-week rest, is recommended for 1 year or 8 courses. This study investigates the efficacy and safety of a 3-weekly adjuvant TS-1 regimen in AGC patients. Methods: We conducted an analysis of 93 patients who underwent gastrectomy with D2 lymphadenectomy and initiated a 3-weekly adjuvant TS-1 regimen between February 2017 and May 2022. The novel regimen consisted of TS-1 at 80 mg/m2/day for 2 weeks, followed by a 1-week rest, with a treatment goal of 1 year or 16 courses. Results: Among the 93 patients, 12 (13%) experienced disease recurrence during a median follow-up of 24.6 months (range: 4.2 to 63.3 months). Of the Stage II patients (n=73), 7 cases (9.5%) had recurrent disease, while 5 cases (25%) in the Stage III group (n=20) experienced recurrence. Recurrence-Free Survival (RFS) rates at 1 year, 3 years, and 5 years were 92.0% (95%CI 86.5 to 97.9), 84.7% (95%CI,76.4% to 93.9%), and 78.6% (95%CI, 65.8% to 94.0%), respectively. A total of 80 patients (86%) completed the adjuvant 3-weekly TS-1 treatment for 1 year or 16 courses, while 25 patients (26.9%) completed the treatment with dose reductions. Adverse events, primarily Grade 1 or 2 diarrhea (28%) and nausea (20%), were manageable. Conclusions: The novel 3-weekly TS-1 regimen as adjuvant therapy exhibited favorable efficacy and tolerable toxicity in AGC patients. These findings suggest the need for further investigation of this regimen in future clinical studies.
Preliminary results of surufatinib (Suru) plus standard chemotherapy (ChT) as second line (2L) treatment of advanced gastric cancer (aGC): A single-arm, phase 2 clinical trial.
Authors: Han Ting , Lin Xiaolin , Zhuo Meng , Jiao Feng , Cui Jiujie , Qiu Xiaoxia , Xiao Xiuying 
Published: January 2024

353 Background: Limited options are available for aGC patients who have failed first line (1L) systemic treatment, and single-agent ChT with paclitaxel (Pac) or irinotecan (Iri) remains the mainstay. Recent studies have suggested improved efficacy with the combination of ChT and antiangiogenic agents in the 2L setting. Suru is a tyrosine kinase inhibitor targeting VEGFR1-3, FGFR1 and CSF-1R. This trial is aimed to evaluate the efficacy and safety of Suru plus Pac or Iri as 2L treatment for aGC. Methods: This single-arm, single center, phase 2 trial was designed to enroll up to 35 histologically confirmed HER2-negative aGC patients with evaluable disease who failed 1L ChT with or without immunotherapy (IO). Eligible patients were administered 21-day cycles of Suru (250mg, po, qd) plus Pac (150mg/m2, iv, d1) or Iri (125mg/m2, iv, d1, d8) per investigator choice for 6 cycles, followed by Suru (250mg, po, qd) maintenance if no disease progression (PD), until intolerable toxicity, PD, or death. The primary endpoint was ORR (per RECIST v1.1), and secondary endpoints included DCR, PFS, OS, and safety. Results: As of Sep 11, 2023, 15 patients were enrolled, and 6 patients remained on treatment. The median follow-up time was 5.77 (95% CI: 3.37~10.13) months. Among all 15 patients, the median age was 66 (range: 33-76) years, 14 (93.3%) were male, and 14 (93.3%) had an ECOG PS of 1. Ten (66.7%) patients had received prior anti-PD-1 antibodies, and all 15 patients received Pac as the standard ChT. All 15 patients were evaluable for tumor response, with 5 PR, 9 SD, and 1 PD as their best overall response (BOR). The ORR and DCR were 33.3% and 93.3%, respectively. The median PFS was 5.23 months, while the OS data was immature yet. The ORR, DCR and PFS seemed comparable between patients with and without prior IO. In terms of safety, the combined treatment was generally well tolerated, treatment-related Grade 3/4 adverse events included neutropenia (6, 40%), leukopenia (1, 6.7%), lymphopenia (1, 6.7%), and proteinuria (1, 6.7%). There were no treatment-related serious adverse events or treatment-related deaths. Conclusions: These results suggested promising anti-tumor activity and a manageable safety profile of Suru plus standard ChT in 2L treatment of aGC. The trial is still ongoing, and more data will be disclosed in the future. Clinical trial information: ChiCTR2200063336 . [Table: see text]
Phase I trial of short-course chemoradiotherapy followed by chemotherapy as total neoadjuvant therapy for patients with potentially resectable gastric cancer.
Authors: Badgwell Brian D. , Das Prajnan , Ikoma Naruhiko , Blum Murphy Mariela A. , Li Jenny Jing , Estrella Jeannelyn , Minsky Bruce D. , Mansfield Paul F. , Ajani Jaffer A. 
Published: January 2024

362 Background: The purpose of this phase I trial was to evaluate the safety and toxicity of preoperative short-course chemoradiotherapy (CXRT) in patients with potentially resectable gastric or gastroesophageal adenocarcinoma as part of a total neoadjuvant therapy (TNT) approach. Methods: Patients with potentially resectable gastric or gastroesophageal adenocarcinoma received CXRT consisting of 30 Gy in 10 fractions with concurrent capecitabine or fluorouracil, followed by systemic therapy for 2 months and then surgery. The primary objective was safety of CXRT with secondary endpoints of pathologic complete response, perioperative complications, and overall survival (OS). Results: A total of 24 patients were treated between March 2021 and December 2022. Ten patients (42%) presented with bleeding and 3 (13%) presented with gastric outlet obstruction. Two patients (8%) had cirrhosis. Clinical nodal involvement was reported in 12 patients (50%). Twenty patients (83%) had poorly differentiated tumors, and 13 (54%) had signet ring cell histology. All patients completed CXRT. CXRT treatment-related toxic effects included grade 3 lymphopenia in 7 patients (29%), grade 4 lymphopenia in 1 (4%), and grade 3 anemia in 1 (4%). After CXRT, 22 patients (92%) completed 2 months of chemotherapy, 1 patient (4%) with a microsatellite-high tumor completed immunotherapy, and 1 patient (4%) underwent resection without systemic therapy. All patients underwent attempted resection, and gastrectomy was performed in 20 (83%). R0 resection rate was 95%. Pathologic complete response was observed in 2 patients (8%), and ≤ 1% viability was observed in an additional 4 (17%). Three patients had surgical complications (grade I in 1 patient [4%], grade IIIb in 1 [4%], and grade IVa in 1 [4%]); there were no deaths within 90 days. The median follow-up time was 20 months, and median OS was not reached. One- and 3-year OS rates from the date of diagnosis were 96% and 80%, respectively. Conclusions: Short-course CXRT (30 Gy in 10 fractions) may be safely used as part of a planned TNT approach. Rates of treatment completion, pathologic response, and survival were promising, supporting further research into TNT for gastric cancer. Clinical trial information: NCT04523818 .
A phase 2, open-label study of amivantamab in patients with previously treated advanced or metastatic gastric or esophageal cancer.
Authors: Kotani Daisuke , Yamaguchi Kensei , Kato Ken , Hara Hiroki , Miura Akinori , Satoh Taroh , Komine Keigo , Kunisaki Chikara , Yabusaki Hiroshi , Hagiwara Akiko , Suzuki Noriko , Toyoizumi Kiichiro , Curtin Joshua C , Chowdhury Sanjib , Knoblauch Roland Elmar , Doi Toshihiko 
Published: January 2024

363 Background: Amivantamab (Ami) is a bispecific antibody targeting epidermal growth factor receptor (EGFR) and mesenchymal epithelial transition receptor (Met) and has immune cell directing activity. Gastric cancer (GC), gastroesophageal junction (GEJ) cancer and esophageal cancer (EC) have been known to express EGFR and Met and these expressions have correlated with poor prognosis. Methods: This open-label, multicenter phase 2 study aims to evaluate the antitumor activity and safety of Ami monotherapy in patients (pts) with advanced or unresectable GC, GEJ cancer and EC who had received at least 2 prior lines (GC/GEJ) or 1 prior line (EC) of systemic therapy. Pts who express varying degrees of EGFR, Met, or both as determined by immunohistochemistry (IHC) were enrolled. Ami was administered intravenously at the recommended Phase 2 dose (RP2D) of 1,050 mg (or 1,400 mg if body weight ≥80 kg) in 28-day cycles. The primary endpoint was objective response rate (ORR) (RECIST 1.1). No hypothesis was planned but approximately 30 pts were to be enrolled in GC and EC cohorts, respectively. Secondary endpoints included disease control rate (DCR), pharmacokinetics (PK) and safety. Results: At the data cut-off of Jul-2023, a total of 59 pts received the RP2D. The 29 and 30 pts had GC/GEJ (all adenocarcinoma) and EC (29 squamous-cell and 1 adenocarcinoma), respectively. Median ages were 66 in GC/GEJ and 60 in EC, and 82.8% and 80.0% of pts were male, and median durations of study treatment were 0.99 and 2.64 months, respectively. The ORRs were 4.3% for GC/GEJ and 10.7% for EC and DCRs were 26.1% and 67.9%, respectively. The Met-high-expression (IHC score ≥2+) tended to be associated with better response of ORR 13.3% and DCR 80.0% compared to Met-low-expression (IHC score 1+/0) of ORR 7.7% and DCR 53.8% in EC. Transcriptomic analysis results from paired baseline/on-treatment EC biopsies will be presented. All 59 pts had adverse events (AEs) and 64.4% of them had AEs with the maximum grade of ≤2. Serious AEs occurred in 27.1% of pts. Conclusions: Ami showed clinical meaningful antitumor activity in EC, especially in Met-high-expression tumors. There was minimal monotherapy activity in GC. No new safety signals were identified in pts with GC and EC, which appeared to be acceptable. Clinical trial information: NCT04945733 .
Camrelizumab plus apatinib after progression on immune checkpoint inhibitors in patients with advanced esophageal squamous cell carcinoma (CAP 02 Re-challenge): A single-arm multicenter, phase II trial.
Authors: Meng Xiangrui , Wang Junsheng , Xia Jin , Wu Tao , Luo Zhiquan , Hong Yong-Gui , Lu Ping , Guo Yanzhen , Ji Yinghua , Zhang Min , Yang Liuzhong , Cheng Peng , Liang Wenchang , Shan Zhengzheng , Fan Qingxia , Wang Feng 
Published: January 2024

364 Background: The optimal therapies for patients with advanced esophageal squamous cell carcinoma (ESCC) who have progressed after immune checkpoint inhibitors (ICIs) are unclear. This phase II single-arm study aimed to assess the efficacy and safety of re-challenge with camrelizumab plus apatinib in this population. Methods: This study enrolled patients with unresectable locally advanced, locally recurrent, or metastatic ESCC who had experienced prior progression on ICI treatment. Enrolled patients received camrelizumab 200 mg intravenously every two weeks along with daily oral apatinib 250 mg. Treatment continued until disease progression, unacceptable toxicity, or patient withdrawal of consent. The primary endpoint was the confirmed objective response rate (ORR). Secondary endpoints included disease control rate (DCR), duration of response (DOR), time to response (TOR), progression-free survival (PFS), overall survival (OS), 3- and 6-month PFS rates, 6-, 9- and 12-month OS rates, and safety. Results: From September 1, 2021, to March 29, 2023, 49 eligible patients were enrolled and given treatment. Among 38 treated patients who had at least one post-baseline efficacy measurement, the ORR and confirmed ORR were 36.8% (95% CI 21.8–54.0) and 13.2% (95% CI 4.4–28.1); the DCR was 89.5% (95% CI 75.2–97.1); the median DOR was 3.0 months; and the median TOR was 2.2 months. Among the 49 treated patients, the median PFS was 4.6 months (95% CI 3.8–6.5) and OS was 7.5 months (95% CI 5.5–13.6). Patients who were both PD-L1 positive and had responded to previous ICI therapy had the longest median PFS (5.7 months, 95% CI 3.9–not reached) and OS (9.6 months, 95% CI 7.5–not reached). Grade ≥ 3 treatment-related adverse events occurred in 34.7% of patients (17/49). Conclusions: This study showed promising efficacy and an acceptable safety profile of camrelizumab plus apatinib for patients with advanced ESCC who had progressed after ICI therapy. The subset of patients who were both PD-L1 positive and had a prior ICI response seemed to benefit most. Clinical trial information: NCT03736863 .