tbuckley/cabot-search huggingface dataset:
AXLerate-OC/GOG-3059/ENGOT OV-66: Results of a phase 3, randomized, double-blind, placebo/paclitaxel-controlled study of batiraxcept (AVB-S6-500) in combination with paclitaxel in patients with platinum-resistant recurrent ovarian cancer.
Authors: Katherine Cynthia Fuh, Zaza Tsitsishvili, Thomas J. Reid, Ugo De Giorgi, Lauren Hand, Rebecca Bowen, Devin Miller, Christof Vulsteke, Sudarshan K. Sharma, Anita M. Chudecka-Głaz, Joyce F. Liu, Lauriane Eberst, Robert Neff, Peter C Lim, David A. Iglesias, Tilley Jenkins Vogel, Tashanna K. N. Myers, Antonio González-Martín, Antonio Gonzalez Martin
Journal: Journal of Clinical Oncology (2024)

LBA5515 Background: Batiraxcept is an Fc-fusion protein engineered to have a 200-fold higher affinity than wild-type AXL for its activating ligand GAS6. Batiraxcept sequesters GAS6 and inhibits its interaction with AXL. The Phase 1b study demonstrated safety with batiraxcept in combination with paclitaxel. Methods: This was a global, placebo-controlled, double-blind, phase III trial (ClinicalTrials.gov identifier: NCT04729608). Patients with PROC were randomly assigned 1:1 to receive intravenous batiraxcept every 2 weeks (D1, 15 every 28 days) with once-a-week IV paclitaxel (D1, 8, 15 every 28 days) or placebo with paclitaxel until disease progression. The primary endpoint was progression-free survival as assessed by investigator-assessed progression-free survival and secondary endpoint was overall survival. The randomization was stratified by platinum-free interval (&lt; 3 months, 3 to 6 months), prior lines (1 to 2, 3 to 4), and prior bevacizumab status (yes, no). Exploratory endpoints include objective response rate, duration of response, quality of life, clinical benefit rate, and pharmacokinetic and pharmacodynamic profile. Results: A total of 366 participants were randomly assigned, and analysis was performed based on intent-to-treat. There were 183 participants who had prior bevacizumab and 177 with no prior bevacizumab. Median PFS (mPFS) was 5.13 months in the batiraxcept + paclitaxel arm and 5.49 months in the control paclitaxel arm, hazard ratio (HR) 1.29 (CI, 1.01 to 1.64; p=0.98). Median OS with batiraxcept + paclitaxel was 14.29 months versus 14.39 months, HR 1.06 (CI 0.77 to 1.46; p=0.64). Objective response rates (ORRs) per RECIST 1.1 were similar in both arms: 25.1% with batiraxcept + paclitaxel versus 26.2% with control paclitaxel arm. An exploratory analysis of the 304 evaluable tumors found that 61 (20%) of tumors had high AXL expression by immunohistochemistry (IHC). In participants with high tumor AXL expression, median PFS was 5.78 months in the batiraxcept + paclitaxel arm and 3.71 months in the control paclitaxel arm, HR 0.55 (CI, 0.31 to 0.98; p=0.042). For high AXL expressing tumors, median OS was 17.8 months in the batiraxcept + paclitaxel cohort and 8.11 months in the paclitaxel cohort, HR 0.32 (CI, 0.14 to 0.73; p=0.006). Conclusions: The addition of batiraxcept to paclitaxel did not improve PFS or OS. However, in AXL high tumors, the PFS and OS were higher in participants who received batiraxcept with paclitaxel compared to paclitaxel alone. Clinical trial information: NCT04729608 .
Overall survival (OS) of phase 3 CodeBreaK 300 study of sotorasib plus panitumumab (soto+pani) versus investigator’s choice of therapy for <i>KRAS</i> G12C-mutated metastatic colorectal cancer (mCRC).
Authors: Marwan Fakih, Lisa Salvatore, Taito Esaki, Dominik Paul Modest, David Páez Lopez-Bravo, Julien Taieb, Michalis Karamouzis, Erika Ruiz-Garcia, Tae Won Kim, Yasutoshi Kuboki, Fausto Angelo Meriggi, David Cunningham, Kun-Huei Yeh, Emily Chan, Joseph Chao, Qui Tran, Chiara Cremolini, Filippo Pietrantonio
Journal: Journal of Clinical Oncology (2024)

LBA3510 Background: In CodeBreaK 300 (NCT05198934), soto+pani was superior to investigator’s choice at the primary analysis of progression-free survival (PFS) in patients (pts) with chemorefractory KRAS G12C-mutated mCRC (Fakih et al. NEJM. 2023). OS data were immature at the PFS analysis. We now report the final OS analysis of CodeBreaK 300. Methods: Study procedures and eligibility criteria were previously reported. The PFS primary endpoint was tested at primary analysis. Key secondary endpoints included OS and objective response. Though the study sample size was not powered for OS, OS hypothesis testing using stratified log-rank test was planned when 50% of pts had observed events per protocol. Stratified Cox hazard ratio (HR) and Kaplan-Meier median estimates are provided. Results: In total, 160 pts were randomly assigned 1:1:1 to soto960+pani (n=53), soto240+pani (n=53), or investigator’s choice of trifluridine/tipiracil, or regorafenib (investigator’s choice; n=54). As of Dec 18, 2023, with a median follow-up of 13.6 months, 82 deaths had occurred with 24, 28, and 30 deaths in the soto960+pani, soto240+pani, and investigator’s choice arms, respectively. Median OS (95% CI) was not reached for soto960+pani, 11.9 months (7.5, NE) for soto240+pani, and 10.3 months (7.0, NE) for investigator’s choice. Hazard ratio (95% CI) was 0.70 (0.41, 1.18) for soto960+pani compared to investigator’s choice and 0.83 (0.49, 1.39) for soto240+pani compared to investigator’s choice. Updated ORR, DOR, and DCR are included in Table. No new safety signals were observed. Conclusions: While CodeBreaK 300 was not powered to detect a statistically significant difference in OS, the study showed a trend toward improved OS for patients randomized to soto960+pani. Together with PFS and response rates, these results support the use of soto960+pani as a potential SOC for pts with chemorefractory KRAS G12C-mutated mCRC. Acknowledgements: The authors thank the patients, investigators, and study staff who contributed to this study; The study was sponsored and funded by Amgen Inc.; Medical writing support was provided by Shubha Dastidar, PhD (CACTUS) and Christopher Nosala, PhD (Amgen Inc.). Clinical trial information: NCT05198934 . [Table: see text]
Radiation therapy (RT)-free pembrolizumab plus chemotherapy (P+C) for PD-L1 TPS ≥50% locally advanced non-small cell lung cancer (LA-NSCLC): Primary analysis from multicenter single arm phase II study (Evolution trial; WJOG11819L).
Authors: Akito Hata, Taira Ninomaru, Hideaki Okada, Yoshihito Kogure, Masahide Oki, Nobuyuki Katakami, Takashi Kijima, Toshihide Yokoyama, Hirotaka Matsumoto, Yuki Sato, Terufumi Kato, Shunichi Sugawara, Takeshi Sawada, Kenichi Yoshimura, Takashi Seto, Kazuhiko Nakagawa, Isamu Okamoto, Nobuyuki Yamamoto
Journal: Journal of Clinical Oncology (2024)

LBA8050 Background: Standard of care for unresectable LA-NSCLC is chemoradiation therapy (CRT) followed by durvalumab (D). Survival curves of P monotherapy/P+C for PD-L1 TPS ≥50% stage IV NSCLC suggested possible comparable survival to CRT for stage III patients (pts). Moreover, some studies of neoadjuvant C+immunotherapy (I) for stage III pts have demonstrated high pathological complete response and major pathological response rates, implying potentially outstanding efficacy of C+I for earlier stage. We thus hypothesized P+C without RT in PD-L1 ≥50% LA-NSCLC pts provides a comparable efficacy to CRT followed by D while avoiding CRT-induced severe toxicities. Methods: This is a phase II study conducted by West Japan Oncology Group. P with platinum plus pemetrexed (PEM) (non-squamous) or P with carboplatin plus nab-paclitaxel (squamous) was administered every 3 weeks without RT. After four cycles of induction P+C, P with PEM (non-squamous) or P alone (squamous) was continued until progression or 2 years. The primary endpoint was 2 year-PFS rate (threshold/expected: 20%/45%). Results: Between May 2020 and February 2022, 21 pts were enrolled. Median age was 73 (range, 53-89). Stage IIIA/B/C included 11 (52%)/7 (33%)/3 (14%), respectively. Histologic subtypes were 14 (67%) adenocarcinoma, 5 (24%) squamous cell carcinoma, and 2 (10%) others. Median follow-up period was 29.9 (range, 0.3-44.2) months. Median number of P administrations was 30 (range, 1-35). The primary endpoint was met with 2-year PFS rate of 67% (90% CI: 46-83%). At the time of data cut-off, 13 (62%) of 21 pts were still progression-free. Median PFS and OS were not reached. Two-year OS rate was 85%. Centrally reviewed tumor response: 8 (38%) CR; 9 (43%) PR; 3 (14%) SD; and 1 (5%) NE were confirmed, resulting in overall response rate (ORR) of 81% and disease control rate of 95%. ORRs/2-year PFS rates of PD-L1 TPS 50-79% and 80-100% were 67%/56% and 92%/75%, respectively. Non-hematological AEs ≥grade 3 were observed in 11 (52%) pts, including: 2 (10%) pneumonitis; 2 (10%) pneumonia; 1 (5%) diarrhea; 1 (5%) ALT elevation; and 1 (5%) acute heart failure. There was one (5%) grade 5 AE (pneumonia). Conclusions: RT-free P+C provided long-lasting responses in approximately two-thirds of pts. Higher PD-L1 TPS cases achieved higher RR, including some CRs and higher 2-year PFS rate. To confirm our hypothesis that RT-free P+C can be a less toxic curative option in selected LA-NSCLC pts with PD-L1 TPS ≥50%, further data is warranted. Clinical trial information: NCT04153734 .
Prospective randomized multicenter phase III trial comparing perioperative chemotherapy (FLOT protocol) to neoadjuvant chemoradiation (CROSS protocol) in patients with adenocarcinoma of the esophagus (ESOPEC trial).
Authors: Jens Hoeppner, Thomas Brunner, Florian Lordick, Claudia Schmoor, Birte Kulemann, Ulf Peter Neumann, Gunnar Folprecht, Tobias Keck, Frank Benedix, Maximilan Schmeding, Ernst Reitsamer, Christiane J. Bruns, Johan F. Lock, Benedikt Reichert, Michael Ghadimi, Kai Wille, Ines Gockel, Jakob R. Izbicki, Stefan Utzolino, Peter Philipp Grimminger
Journal: Journal of Clinical Oncology (2024)

LBA1 Background: The most effective multimodal approach for treatment of resectable locally advanced esophageal adenocarcinoma (EAC) is under debate. A prior ranking question is if neoadjuvant chemoradiation therapy or perioperative chemotherapy is superior. ESOPEC (NCT02509286) is a multicenter prospective randomized trial comparing neoadjuvant CROSS (41.4Gy plus carboplatin/paclitaxel) followed by surgery versus perioperative FLOT (5-FU/ leucovorin/oxaliplatin/docetaxel) and surgery for the curative treatment of EAC. Methods: Patients with cT1 cN+ cM0 or cT2-4a cNany cM0 resectable EAC were eligible. The primary endpoint is overall survival (OS; 90% power; hazard ratio [HR] 0.645, 218 events needed; one sided significance level of 2.5%). Analysis is by intention-to-treat in all randomized patients. The effect of treatment on OS is estimated using Cox regression stratified by study site, and including N stage (N0, N+), and age as covariates. Results: Between Feb 2016 and Apr 2020, 438 patients from 25 sites in Germany were randomly assigned to two treatment groups (221 FLOT; 217 CROSS). Baseline characteristics (male sex 89.3%, median age 63 [range 30-86], cT3/4 80.5%; cN+ 79.7%) were well balanced between both arms. Neoadjuvant treatment was started in 403 patients (207 FLOT; 196 CROSS). Surgery was done in 371 patients (191 FLOT; 180 CROSS). R0 resection was achieved in 351 patients (180 FLOT; 171 CROSS). 90 days postsurgical mortality was 4.3% (3.2% FLOT; 5.6% CROSS). After a median follow up of 55 months, 218 patients had died (97 FLOT; 121 CROSS). Median OS was 66 (95% CI 36 – not estimable) months in the FLOT arm, and 37 (95% CI 28 – 43) months in the CROSS arm. The 3-year OS rates were 57.4% (95% CI 50.1 – 64.0%) for FLOT and 50.7% (95% CI 43.5 – 57.5%) for CROSS (HR 0.70, 95% CI 0.53-0.92, p=0.012). In 359 patients with available tumor regression status, pathological complete response was achieved in 35 (19.3%, 95%-CI 13.9 – 25.9%) in FLOT and in 24 (13.5%, 95%-CI 8.8 – 19.4%) in CROSS. Conclusions: Perioperative FLOT improves survival in resectable EAC compared to neoadjuvant CROSS. Funding: The trial was funded by the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation), project number 264590883. Clinical trial information: NCT02509286 .
Combination or sequence of vemurafenib, cobimetinib, and atezolizumab in high-risk, resectable melanoma (NEO-TIM): Primary results.
Authors: Paolo Antonio Ascierto, Pietro Quaglino, Francesco Spagnolo, Massimo Guidoboni, Michele Del Vecchio, Michele Guida, Ketty Peris, Luisa Fioretto, Virginia Caliendo, Riccardo Marconcini, Paola Queirolo, Corrado Caraco, Mocellin Simone, Maria Grazia Vitale, Domenico Mallardo, Diana Giannarelli, Miriam Paone, Claudia Trojaniello, Daniela Massi, Vanna Chiarion-Sileni
Journal: Journal of Clinical Oncology (2024)

LBA9513 Background: Adjuvant immune checkpoint blockade (ICB) and target therapy (TT) improve outcomes of patients (pts) with high-risk resectable melanoma. Prospective neoadjuvant (NAT) clinical trials with TT or ICB are now running in a subgroup of high-risk melanoma pts with pooled overall promising preliminary results of high rates of pathologic complete responses (pCRs, 30–50%) and early data of positive correlation between pCR and relapse-free survival (RFS). We aimed to conduct a randomized, non-comparative phase II trial to define the role of NAT plus adjuvant TT and ICB, given in combination or sequence, in pts with high risk surgically resectable melanoma. Methods: 95 pts with resectable, RECIST measurable stage IIIB/IV, BRAF-mutant melanoma were randomized 1:1 in arm A and arm B, respectively, to receive NAT vemurafenib (V) and cobimetinib (C) for 6 weeks or NAT triplet combination (V and C plus atezolizumab (A), followed by complete lymph node dissection (CLND). Patients with BRAF wild-type melanoma were included in Arm C with NAT C and A. All pts had 17 cycles of A 1200 mg IV q3w post-CLND. Primary endpoint is pCR centrally/independently determined defined as residual cancer burden 0. Secondary endpoints are RFS, Overall Survival (OS), Pathological Overall Response Rate (pORR), Safety, Biomarkers analyses. Results: At data cut-off Dec 15, 2023, 29% of pts were female, median age was 59 yrs, 60% had a clinical stage IIIC, and median f/u was 17 months (IQR: 10-22). The Major Pathological Response (defined as pCR/near-pCR) was reached in 13 (45%), 10 (34%) and 13 (36%) pts in arm A, B and C, respectively. Five (17%), 4 (14%) and 6 (16%) pts did not receive surgery, and 1 (3%) patient of arm B is still under evaluation of pathological respose rate (pRR). At 12 months,RFS was 78%, 86% and 82% in arm A, B and C, respectively. Nearly 19% of pts treated in arm C were discontinued before surgery due to PD, AEs or patient’s withdrawn consent, 7% and 14% in arm B and A, respectively, due to comorbidities and AEs. G3-G4 toxicity was observed in 38%, 24% and 22% of pts in arm A, B and C. Conclusions: Pts treated with TT upfront had highest response to NAT but the pts who received IO as NAT had a better RFS. Clinical trial information: NCT04722575 . [Table: see text]
Nivolumab (NIVO) plus ipilimumab (IPI) vs lenvatinib (LEN) or sorafenib (SOR) as first-line treatment for unresectable hepatocellular carcinoma (uHCC): First results from CheckMate 9DW.
Authors: Peter Robert Galle, Thomas Decaens, Masatoshi Kudo, Shukui Qin, Leonardo Fonseca, Bruno Sangro, Hatim Karachiwala, Joong-Won Park, Edward Gane, Matthias Pinter, David Tai, Armando Santoro, Gonzalo Pizarro, Chang-Fang Chiu, Michael Schenker, Aiwu Ruth He, Qi Wang, Caitlyn Stromko, Joseph Hreiki, Thomas Yau
Journal: Journal of Clinical Oncology (2024)

LBA4008 Background: First-line therapies based on programmed death ligand 1 (PD-L1) inhibitors are standard of care (SOC) in uHCC and demonstrate improved outcomes over SOR; however, prognosis remains poor and there is an unmet need for alternative therapies with long-term benefits. Second-line NIVO + IPI demonstrated clinically meaningful efficacy and manageable safety in SOR-treated patients (pts) with HCC in CheckMate 040, leading to its accelerated approval in the United States. We report first results from the preplanned interim analysis of the phase 3, open-label, randomized CheckMate 9DW trial evaluating the efficacy and safety of NIVO + IPI vs LEN or SOR as first-line therapy for pts with uHCC (NCT04039607). Methods: Adult pts with previously untreated HCC not eligible for curative surgical or locoregional therapies, Child-Pugh score 5–6, and ECOG performance status 0–1 were included. Pts were randomly assigned 1:1 to receive NIVO 1 mg/kg + IPI 3 mg/kg Q3W (up to 4 cycles) followed by NIVO 480 mg Q4W or investigator’s choice of LEN 8 mg or 12 mg QD or SOR 400 mg BID until disease progression or unacceptable toxicity. NIVO was given for a maximum of 2 years. The primary endpoint was overall survival (OS). Secondary endpoints included objective response rate (ORR) and duration of response (DOR) per blinded independent central review (BICR) using RECIST v1.1. Results: In total, 668 pts were randomized to NIVO + IPI (n = 335) or LEN/SOR (n = 333); among 325 pts treated in the LEN/SOR arm, 275 (85%) received LEN. After a median (range) follow-up of 35.2 (26.8–48.9) months (mo), median OS was 23.7 mo with NIVO + IPI vs 20.6 mo with LEN/SOR (HR, 0.79; 95% CI, 0.65–0.96; P = 0.0180) (Table), with respective 24-mo OS rates (95% CI) of 49% (44–55) vs 39% (34–45). ORR was higher with NIVO + IPI (36%) vs LEN/SOR (13%; P &lt; 0.0001); complete response was observed in 7% of pts with NIVO + IPI vs 2% with LEN/SOR. Median DOR was 30.4 mo with NIVO + IPI vs 12.9 mo with LEN/SOR (Table). A summary of treatment-related adverse events (TRAEs) is shown in the Table. Conclusions: NIVO + IPI demonstrated statistically significant OS benefit vs LEN/SOR in pts with previously untreated uHCC, as well as higher ORR and durable responses with a manageable safety profile. These results support this combination as a potential new first-line SOC for uHCC. Clinical trial information: NCT04039607 . [Table: see text]
Sacituzumab govitecan (SG) vs docetaxel (doc) in patients (pts) with metastatic non-small cell lung cancer (mNSCLC) previously treated with platinum (PT)-based chemotherapy (chemo) and PD(L)-1inhibitors (IO): Primary results from the phase 3 EVOKE-01 study.
Authors: Luis G. Paz-Ares, Oscar Juan-Vidal, Giannis Socrates Mountzios, Enriqueta Felip, Niels Reinmuth, Filippo de Marinis, Nicolas Girard, Vipul M. Patel, Takayuki Takahama, Scott Peter Owen, Douglas Reznick, Firas Benyamine Badin, Irfan Cicin, Sabeen Fatima Mekan, Riddhi Patel, Eric Zhang, Divyadeep Karumanchi, Marina Chiara Garassino
Journal: Journal of Clinical Oncology (2024)

LBA8500 Background: In pts with mNSCLC who progress on PT-based chemo and IO, doc is standard of care, but outcomes remain poor. SG, a Trop-2-directed antibody drug conjugate, showed durable response and tolerable safety in pretreated mNSCLC. We report results from the phase 3, randomized, open-label EVOKE-01 study comparing SG vs doc. Methods: Pts with mNSCLC with disease progression after PT-based chemo and IO were randomized 1:1 (stratified by histology, best response to last prior IO, and prior treatment for actionable genomic alterations [yes/no]) to receive SG (10 mg/kg IV, days 1 and 8) or doc (75 mg/m 2 IV, day 1) in 21-day cycles until progression or unacceptable toxicity. The primary endpoint was overall survival (OS); key secondary endpoints were investigator assessed progression-free survival (PFS) and objective response rate (ORR), patient-reported outcomes (PROs), and safety. Results: As of Nov 29, 2023, 603 pts were randomized. Median (range) age was 65 (31–84) yrs; 55% had 1 prior therapy line. The study was not statistically significant for OS. A numerical improvement in OS, favoring SG, was seen (HR 0.84 [95% CI, 0.68–1.04; 1-sided P = 0.0534]) including in pts with squamous and nonsquamous histology. PFS and ORR are shown in the Table. A clinically meaningful difference in median OS favoring SG (3.5 mo) was seen in pts without response to last prior IO. PROs were improved with SG vs doc. Grade ≥3 treatment-emergent adverse event (TEAE) incidence was 66.6% (SG) and 75.7% (doc). Treatment-related AEs led to discontinuation in 6.8% (SG) and 14.2% (doc). Conclusions: Although statistical significance was not met, SG showed numerical improvement in OS vs doc. Results were consistent across all major subgroups including histology. Clinically meaningful improvement in OS was noted in pts without response to prior IO. SG was better tolerated than doc; observed safety was consistent with the known profile. Clinical trial information: NCT05089734 . [Table: see text]
A phase III randomized, double-blinded, placebo-controlled study of suvemcitug combined with chemotherapy for platinum-resistant ovarian cancer (SCORES).
Authors: Guangwen Yuan, Lingying Wu, Qingshui Li, Ge Lou, Jundong Li, Xiaowei Liu, Danbo Wang, Chen Yang, Shuguang Sun, Jiajing Zhang
Journal: Journal of Clinical Oncology (2024)

LBA5516 Background: Suvemcitug is a new-generation recombinant humanized anti-VEGF rabbit monoclonal antibody. In the previous P1b study, Suvemcitug demonstrated its favorable safety profile and efficacy signals when combo with chemotherapy in platinum-resistant ovarian cancer (PROC). SCORES is the first randomized, double-blind, placebo-controlled phase III clinical trial to confirm the efficacy of Suvemcitug combo with chemo in PROC, whether or not previously received antiangiogenic agents or PARP inhibitors. Methods: Eligible patients had progressed during platinum-based therapy or within 6 months after ≥4 cycles of platinum-based therapy with at least one measurable lesion. After the investigators chose chemotherapy (CT) (weekly paclitaxel 80 mg/ m 2 d1, 8, 15 &amp; 22 q4w, pegylated liposomal doxorubicin 40 mg/m 2 d1 q4w or topotecan 4 mg/m 2 d1, 8 &amp; 15 q4w), patients were randomly assigned (2:1) to either Suvemcitug (1.5 mg/kg q2w) or placebo combine with CT until progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS) by blinded independent review committee (BIRC) according to the RECIST 1.1. Key secondary end point is the overall survival (OS). Results: A total of 421 patients were enrolled between June 2021 and June 2023 in China. As the data cut off of the primary efficacy analysis (8 December 2023), 197 PFS events (70.1%) in Suvemcitug arm and 111 PFS events (79.3%) in placebo arm had occurred with the median follow-up of 14.36 and 14.26 months, respectively. The median PFS by BIRC was 5.49 months in Suvemcitug arm versus 2.73 months in placebo arm (hazard ratio[HR] 0.46, p&lt;0.0001). OS data are immature. 42.7% and 50.7% of patients are deceased in Suvemcitug arm or placebo arm respectively, and there is a trend of OS benefit trend: median OS 16.07 months vs. 14.88 months, HR 0.79, p=0.1244. Efficacy results are summarized below. Treatment-emergent adverse events (TRAEs) occurred in all patients in Suvemcitug arm, with the most common being neutrophil count decreased, white blood cell count decreased and platelet count decreased. No Suvemcitug-related grade 5 TEAE occurred. Conclusions: To the best of our knowledge, this is the first double-blinded phase III study demonstrated promising antitumor activity of anti-angiogenic agent in patients with PROC. The improvement in PFS, ORR and DCR gained by adding Suvemcitug to single-agent CT was observed with no new safety concern. Clinical trial information: NCT04908787 . [Table: see text]