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(Small Cell Lung Cancer)

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SCLC (Small Cell Lung Cancer)AmrubicinIfinatamab deruxtecanLurbinectedinTopotecanRecruitingAustraliaAustriaBelgiumBrazilCanadaChinaCzechiaFranceGermanyGreeceHungaryItalyJapanKorea, Republic ofNetherlandsPolandPortugalRomaniaSpainSwitzerlandTaiwanTurkeyUnited KingdomUnited States 8NCT06203210Phase 3IDeate-Lung02
A Study of Ifinatamab Deruxtecan Versus Treatment of Physician’s Choice in Subjects With Relapsed Small Cell Lung Cancer

A Study of Ifinatamab Deruxtecan Versus Treatment of Physician’s Choice in Subjects With Relapsed Small Cell Lung Cancer

SCLC (Small Cell Lung Cancer)DurvalumabOther: PlaceboTremelimumabActiveNot Yet RecruitingArgentinaBelgiumCanadaChinaCzechiaGermanyIndiaItalyJapanKorea, Republic ofNetherlandsPolandRussian FederationSpainTaiwanTurkeyUnited KingdomUnited StatesVietnam 9NCT03703297Phase 3ADRIATIC
Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy

Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy

NSCLC (Non-Small Cell Lung Cancer)Other CancersSCLC (Small Cell Lung Cancer)(vic-)trastuzumab duocarmazineRecruitingUnited States 0NCT02146170
Tissue Procurement and Natural History Study of People With Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Extrapulmonary Small Cell Cancer, Pulmonary Neuroendocrine Tumors, and Thymic Epithelial Tumors

Tissue Procurement and Natural History Study of People With Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Extrapulmonary Small Cell Cancer, Pulmonary Neuroendocrine Tumors, and Thymic Epithelial Tumors

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Impact of Zipalertinib on EGFR Ex20ins NSCLC Post Amivantamab

KEY TAKEAWAYS

  • The study aimed to investigate the efficacy and safety of zipalertinib in NSCLC with EGFR ex20ins after amivantamab.
  • Researchers noticed that zipalertinib demonstrated promising efficacy and safety in patients with NSCLC.

Zipalertinib (CLN-081, TAS6417) is a novel EGFR tyrosine kinase inhibitor (TKI) that achieved a confirmed objective response rate (ORR) of 41% with manageable safety in a phase 1/2a study involving patients with Non-Small Cell Lung Cancer (NSCLC) EGFR exon 20 insertion (ex20ins) NSCLC who had received prior platinum-containing chemotherapy (JCO 2023).

Antonio Passaro and the team aimed to present data from the phase 2b REZILIENT1 study focusing on cohort C patients with EGFR ex20ins mutant NSCLC who progressed after treatment with amivantamab.

They performed an inclusive analysis involving patients who had progressed after at least 1 prior treatment, including amivantamab. These patients were enrolled to receive zipalertinib at a dosage of 100 mg orally twice daily. Tumor response was assessed by the investigator according to RECIST v1.1 criteria. Patients with stable, asymptomatic, or treated brain metastases were also permitted to participate in the study.

About the 29 March 2024 data cut-off (DCO), 45 patients had been enrolled, with a median age of 62 years (range 33-85) and a median of 3 lines of prior therapy (range 1-6). Prior treatment included platinum-based chemotherapy in 43 patients (96%), anti-PD1/L1 therapy in 20 patients (44%), and EGFR TKIs in 22 patients (49%). A history of brain metastasis was present in 22 patients (49%).

Treatment-related adverse events (TRAEs) occurring in ≥10% of patients included rash (38%), paronychia (36%), anemia (24%), dry skin (20%), dermatitis acneiform (16%), nausea (16%), and stomatitis (11%). Grade 3 TRAEs were reported in 14 patients (31%), including anemia (4), rash (3), and pneumonitis/ILD (3). There were no grade 4 or 5 TRAEs. TRAEs leading to dose reductions and discontinuations occurred in 3 patients (7%) each.

At DCO, 30 patients were evaluable for response (having at least 2 treatment assessments or progression/death), of which 1 patient (3%) achieved a complete response (CR), 11 patients (37%) had a partial response (PR), and 15 patients (50%) had stable disease (SD). The overall response rate (ORR) was 40%, and the disease control rate (CR + PR + SD) was 90%. The median duration of response was not yet estimable, and the median progression-free survival (PFS) was 9.7 months.

The study concluded that zipalertinib demonstrated promising anti-tumor activity and a manageable safety profile in heavily treated patients with NSCLC harboring EGFR ex20ins mutations who progressed after prior treatment with amivantamab. These findings support the potential of zipalertinib as a viable therapeutic option in this challenging patient population.

The trial was sponsored by Cullinan Therapeutics Inc.

Source: https://cslide.ctimeetingtech.com/esmo2024/attendee/confcal/show/session/105

Clinical Trial: https://clinicaltrials.gov/study/NCT04036682

Passaro A, Yu H.A, Nguyen D, et al. (2024). “Safety and anti-tumour activity of zipalertinib in NSCLC patients (pts) with EGFR exon 20 insertion (ex20ins) mutations who received prior amivantamab.” Presented at ESMO 2024 (Abstract 1254MO).

Evaluating Alectinib Efficacy in Patients With ALK+ NSCLC

KEY TAKEAWAYS

  • The study aimed to investigate the efficacy of adjuvant alectinib vs chemotherapy in resected ALK+ NSCLC.
  • Researchers noted a significant DFS benefit with alectinib in resected ALK+ NSCLC, regardless of EML4-ALK variant and with implications for TP53 status.

ALINA (NCT03456076) is a global phase III randomized trial assessing the efficacy and safety of adjuvant alectinib versus chemotherapy in patients with resected stage IB (≥4 cm)–IIIA ALK+ non-small cell lung cancer (NSCLC) according to AJCC 7th edition criteria. The trial demonstrated a significant disease-free survival (DFS) advantage for alectinib over chemotherapy, with a hazard ratio of 0.24 (95% CI: 0.13–0.43, P<0.0001) in the intention-to-treat (ITT) population.

Ben J. Solomon and the team aimed to present the exploratory biomarker analyses derived from baseline tissue samples and matched samples from patients who experienced recurrence while on alectinib.

They performed an inclusive analysis of the biomarker-evaluable population (BEP), a subset of the ALINA ITT population. This group comprised patients who had sufficient baseline tumor tissue available for analysis and received valid results from the FoundationOne®CDx assay. Notably, patients from China were excluded from the BEP due to the lack of available baseline tissue samples.

The baseline characteristics and disease free survival (DFS), were noted between the ITT population (N=27) and the BEP (n=193). At the data cut-off in June 2023, 13 DFS events occurred in the alectinib group, while 41 events were recorded in the chemotherapy group within the BEP. A total of 81% of patients in the BEP had EML4-ALK fusions, with the most common variants being V1/V3; alectinib demonstrated a DFS benefit compared to chemotherapy, regardless of the EML4 variant.

The most frequently altered genes included CDKN2A, CDKN2B, TP53, and MTAP, with CDKN2A, CDKN2B, and MTAP alterations often co-occurring within single tumors. TP53 mutations were less common in patients with early-stage NSCLC from ALINA (24%) compared to those with metastatic NSCLC in the ALEX trial (NCT02075840) (41%).

In the alectinib arm, patients with wild-type (WT) TP53 exhibited a trend toward improved DFS compared to those with mutated TP53; this trend was not observed in the chemotherapy arm. No correlation between DFS and alterations in CDKN2A, CDKN2B, or MTAP was found for alectinib. Additionally, no ALK on-target resistance mechanisms were identified in the recurrence analysis.

The study concluded that alectinib provides a significant DFS benefit in patients with resected ALK+ NSCLC, independent of the EML4-ALK variant. Additionally, patients with WT TP53 at baseline exhibited a trend toward improved DFS compared to those with mutated TP53, highlighting the potential influence of TP53 status on treatment outcomes.

The trial was sponsored by the Hoffmann-La Roche.

Source: https://cslide.ctimeetingtech.com/esmo2024/attendee/confcal/show/session/162

Clinical Trial: https://clinicaltrials.gov/study/NCT03456076

Solomon B.J, Wu Y.L, Dziadziuszko R, et al. (2024). ” – ALINA: Exploratory biomarker analyses in patients (pts) with resected ALK+ non-small cell lung cancer (NSCLC) treated with adjuvant alectinib vs chemotherapy (chemo).” Presented at ESMO 2024 (Abstract 1206MO).

Adaptive Approaches to NSCLC: Targeting ICI Resistance Pathways

KEY TAKEAWAYS

  • The PIONeeR phase 2 trial aimed to investigate targeting 4 resistance pathways to improve outcomes in advanced NSCLC after anti-PD-(L)1 therapy.
  • The primary endpoint was to determine DCR.
  • Researchers noted prolonged responses in some patients, indicating the promise of durvalumab combinations despite no arm surpassing docetaxel.

Anti-PD-(L)1 therapies are approved for treating advanced non-small cell lung cancer (NSCLC), but many patients progress during treatment, leaving few options available post-therapy.

In this PIONeeR trial, Michiel S. Van der Heijden and the team aimed to address this issue by targeting four major resistance pathways to overcome anti-PD-(L)1 resistance.

They performed an inclusive analysis in this open-label, multicenter, controlled randomized study utilizing a Bayesian adaptive design. Advanced patients with NSCLC having disease progression after sequential or concomitant PD-(L)1 and platinum-based chemotherapy were eligible for participation.

Patients were randomly assigned to 1 of 5 arms: Arm A received Durvalumab + Monalizumab, Arm B received Du + Oleclumab, Arm C received Du + Ceralasertib, Arm D (control) received Docetaxel, and Arm E received Du + Savolitinib.

The primary endpoint was the 12-week Disease Control Rate (12-w DCR) assessed by RECIST1.1. Key secondary endpoints included Duration of Response (DoR), Overall Response Rate (ORR), Progression-Free Survival (PFS), overall survival (OS), and safety. Interim analyses applied a futility boundary of 30%, with a combination arm considered effective if there was a high probability (P ≥ 90%) for the 12-w DCR to exceed that of Arm D.

About 114 patients with NSCLC were randomized across the trial arms: A, n=28; B, n=3; C, n=32; D, n=31; and E, n=20. Arms B and E were prematurely closed due to a lack of efficacy. Of these 11 patients in arm D withdrew prior to treatment. The 12-w DCR was 54.5% (95% CI [34.0%; 74.3%]) in the control arm compared to 24.1% [10.7%; 41.0%] in arm A, 0% in arm B, 50% [33.1%; 66.9%] in arm C, and 13.6% [3.0%; 30.4%] in arm E; P values were 1.2% and 36.8% for arms A and C, respectively.

No significant improvements in PFS or OS were observed in the experimental arms compared to arm D. However, 5 patients achieved a partial response (PR) by RECIST in arm C, with a median DoR of 5.6 months [2.1; 9.7]. No unexpected safety signals were reported. Preliminary biomarker analyses will be presented during the meeting.

The study concluded that while no experimental arm exceeded the outcomes of docetaxel, the presence of long DoR in some patients with NSCLC indicates that durvalumab combinations may be highly effective. Ongoing biomarker research aims to identify patients who are most likely to benefit from these combination treatments.

The trial was sponsored by the Assistance Publique Hopitaux De Marseille.

Source: https://cslide.ctimeetingtech.com/esmo2024/attendee/confcal/show/session/240

Clinical Trial: https://clinicaltrials.gov/study/NCT03833440

Tomasini P, Cropet C, Jeanson A, et al. (2024). “Precision immuno-oncology for advanced non-small cell lung cancer (NSCLC) patients with PD-(L)1 inhibitors resistance (PIONeeR): A phase Ib/IIa clinical trial targeting identified resistance pathways.” Presented at ESMO 2024 (Abstract LBA8).

Belomethason Inhalation Reduces RIP in NSCLC During RT

Belomethason Inhalation Reduces RIP in NSCLC During RT

KEY TAKEAWAYS

  • The phase 2 trial aimed to investigate belomethason inhalation’s impact on reducing RIP in patients with NSCLC.
  • The primary endpoint is RIP.
  • Researchers noticed inhaled corticosteroids cut RIP in NSCLC, warranting phase III validation.

Thoracic radiotherapy (RT) is crucial in the comprehensive treatment of non-small cell lung cancer (NSCLC). However, radiation-induced lung injury (RILI) is a significant long-term complication, with limited treatment options. Approximately 30% of patients receiving thoracic RT for lung or breast cancer may develop radiation-induced pneumonitis (RIP). Despite its prevalence, the mechanisms behind RIP are not well understood.

Jie Zhang and the team aimed to investigate the potential of belomethason propionate inhalation to mitigate RIP in patients with NSCLC.

They performed an inclusive analysis involving all eligible patients with NSCLC from Shanghai Pulmonary Hospital between 2019 and 2021. Patients were randomly assigned in a 1:1 ratio to either the corticosteroid group or the control group. All participants received curative radiotherapy for lung lesions. Patients in the corticosteroid group inhaled beclomethasone propionate once daily during radiotherapy, while those in the control group received only radiotherapy.

Other background treatments were administered at the treating physicians’ discretion according to local guidelines. The primary endpoint was the incidence of RIP, with secondary endpoints including overall response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and toxicity.

About 292 patients were enrolled in the study, with 142 assigned to the corticosteroid prevention group and 150 to the control group. Baseline characteristics were well balanced between the two groups. The results demonstrated that the incidence of all-grade radiation pneumonitis was 35.3% in the prevention group compared to 52.8% in the control group (P=0.03).

The incidence of grade ≥3 radiation pneumonitis was 12% in the prevention group versus 28.2% in the control group, representing a statistically significant reduction (P=0.01). The ORR was 40.9% in the prevention group and 35.9% in the control group, with no significant difference (P=0.65).

After a 2-year follow-up, no difference in OS was observed between the groups (P=0.425). However, the incidence of hyperglycemia was higher in the prevention group compared to the control group (P=0.025).

The study concluded that the addition of inhaled corticosteroids to radiotherapy significantly reduced the incidence of RIP in patients with NSCLC. These results warrant further confirmation through phase III clinical studies.

The trial was sponsored by Tongji University.

Source: https://cslide.ctimeetingtech.com/esmo2024/attendee/confcal/show/session/162

Clinical Trial: https://clinicaltrials.gov/study/NCT03886441

ZHANG J, Wu Q, Wu H, et al. (2024). “The addition of belomethason propionate inhalation to radical radiotherapy for patients with locally advanced non-small cell lung cancer: A randomized controlled, open-label phase II study.” Presented at ESMO 2024 (Abstract 1242MO).

Efficacy of Low vs Standard Pembrolizumab in NSCLC

KEY TAKEAWAYS

  • The DEDICATION-1 phase 3 trial aimed to investigate if reduced-dose pembrolizumab is as effective as standard dosing in stage IV NSCLC.
  • Researchers noticed a 3.2% difference in one-year survival, meeting the criteria to continue the study.

Immune checkpoint inhibitors have demonstrated improved overall survival (OS) for patients with metastatic non-small cell lung carcinoma (NSCLC). However, optimal dosing and patient selection remain under discussion. This study shows that reducing the standard dose of pembrolizumab (150-200 mg every three weeks [Q3W] or 400 mg every six weeks [Q6W]) to either 300 mg Q6W or 100 mg Q3W could maintain efficacy without compromising therapeutic outcomes.

Michel Van den Heuvel and the team aimed to assess the efficacy and safety of these reduced pembrolizumab doses in stage IV NSCLC.

Inclusive analysis was performed for an open-label non-inferiority trial comparing reduced-dose pembrolizumab (300 mg Q6W or 100 mg Q3W) with standard-dose pembrolizumab (400 mg Q6W or 150-200 mg Q3W) in patients with NSCLC eligible for pembrolizumab-based regimens.

The trial included patients receiving pembrolizumab either as monotherapy or in combination with chemotherapy. An interim analysis was preplanned after the first 250 patients were included and followed for 1 year. A clinically relevant difference of 10% in 1-year OS between arms was established as the stopping criterion for the interim analysis.

About 256 patients were analyzed in the interim review. Among the 123 patients in the standard dose group, 8 received pembrolizumab at 150 mg Q3W and 115 received it at 400 mg Q6W. In the reduced dose group of 133 patients, 5 were administered 100 mg Q3W and 128 received 300 mg Q6W. Pembrolizumab was combined with chemotherapy in 49.2% of the patients.

The 1-year OS was 56.6% (95% CI: 48.3% − 66.4%) for the standard dose and 53.4% (95% CI: 45.1% − 63.3%) for the reduced dose. Median OS was 15.9 months (95% CI: 11.8 – 23.2) for the standard dose and 13.1 months (95% CI: 10.3 – 15.4) for the reduced dose. There was no significant difference in OS between the 2 groups (P = 0.45). Median progression-free survival (PFS) was 7.3 months (95% CI: 6.3 – 9.8) for the standard dose and 7.3 months (95% CI: 5.6 – 10.8) for the reduced dose.

The study concluded that, with an observed difference in one-year survival of 3.2%, the predetermined criterion for continuing inclusion was met.

The trial was sponsored by the Radboud University Medical Center.

Source: https://cslide.ctimeetingtech.com/esmo2024/attendee/confcal/show/session/105

Clinical Trial: https://clinicaltrials.gov/study/NCT04909684

Heuvel M.V.D, Noort V.V.D, Heine R.T, (2024). “Low dose versus standard dose pembrolizumab for treatment of stage IV stage non-small cell lung carcinoma: Results of the pre-planned interim analysis of the NVALT-30 clinical trial.” Presented at ESMO 2024 (Abstract 1258MO).

Long-Term Outcomes of Neo Nivo ± Ipi in NSCLC

KEY TAKEAWAYS

  • The phase 2 trial aimed to investigate the long-term clinical efficacy of neo ICB with nivo and nivo+ipi in NSCLC.
  • The primary endpoints were to determine MPR, PCR, EFS, and OS.
  • The Neo ICB with nivo or nivo+ipi shows promising long-term efficacy in resectable NSCLC; further research is needed.

Neoadjuvant (neo) and perioperative immune checkpoint blockade (ICB) have significantly transformed the management of resectable non-small cell lung cancer (NSCLC). These therapies have introduced new possibilities for improving patient outcomes.

Joshua Reuss and the team aimed to present the inaugural pooled analysis of 5-year clinical outcomes from 2 early-phase trials, NEOSTAR and CA209-259, investigating neo-ICB in NSCLC.

In NEOSTAR (NCT03158129), patients were randomly assigned (1:1) to receive IV nivolumab (nivo) 3mg/kg every 2 weeks (q2w) x 3 (doses) with or without IV ipilimumab (ipi) 1mg/kg on day 1 only. In comparison, CA209-159 (NCT02259621) involved patients in sequential arms with different combinations of nivo and ipi (nivo 3mg/kg q2w x 2, nivo 3 mg/kg q2w x 3 w/ I 1mg/kg on day 1 only, nivo 3mg/kg q2w x 3). Both trials included patients with stage I-IIIA NSCLC (AJCC 7th).

The team performed a meta-analysis of individual patient data to estimate the rates and hazard ratios (HR) for major pathologic response (MPR), pathologic complete response (PCR), event-free survival (EFS), overall survival (OS), and HR.

The results showed that 60 patients received nivo and 30 received nivo+ipi. The MPR rates were (28.1% (95% CI: 17.4, 42.1) and 33.3% (95% CI: 19.0, 51.7) for nivo+ipi. The PCR rates were (95% CI: 3.5, 18.5) and 26.7% (95% CI: 13.9, 45.0).

With a median follow-up of 68.4 months for nivo and 62.1 months for nivo+ipi, median EFS and OS were not reached. For the combined 90-patient cohort, MPR showed high 5-year EFS and OS rates of 74.0% (95% CI 52.9, 86.8) and 81.7% (95% CI: 61.4, 92.0), respectively. Patients with PCR had a 5-year EFS and OS of 77.5% (95% CI: 44.9, 92.2) and 85.5% (95% CI: 52.9, 96.2), respectively.

MPR showed a trend toward better EFS with nivo+ipi, and pre-treatment PD-L1 ≥1% was linked to significantly improved EFS with nivo. KRAS co-mutations with STK11, KEAP, and SMARCA4 were linked to worse EFS in nivo.

The study concluded that neo-ICB with nivo alone or combined with ipi shows promising long-term clinical efficacy in resectable NSCLC. Further biomarker-driven research is necessary to identify patient subgroups who would benefit from these therapies.

The trial was sponsored by M.D. Anderson Cancer Center.

Source: https://cslide.ctimeetingtech.com/esmo2024/attendee/confcal/show/session/117

Clinical Trial: https://clinicaltrials.gov/study/NCT03158129

Reuss J, Leung CH, Rosner S, et al. (2024). “Neoadjuvant nivolumab and nivolumab+ipilimumab in resectable non-small cell lung cancer: Combined analysis of 5-year outcomes from NEOSTAR and CA209-159,” Presented at ESMO 2024 (Abstract 1209MO).

Efficacy of Zidesamtinib in ROS1+ NSCLC: Phase I/II Study

KEY TAKEAWAYS

  • The ARROS-1 phase 1&2 trial aimed to investigate the efficacy and safety of zidesamtinib in ROS1+ NSCLC.
  • Researchers noticed that zidesamtinib showed promising efficacy and a favorable safety profile in ROS1+ NSCLC.

Zidesamtinib is a brain-penetrant, TRK-sparing, highly selective ROS1 tyrosine kinase inhibitor (TKI) with activity against various ROS1 fusions and resistance mutations, including G2032R.

Benjamin Besse and the team aimed to evaluate the drug’s efficacy and safety in patients with ROS1+ Non -Small Cell Lung Cancer (NSCLC), focusing on those who have previously undergone treatment and those with CNS metastases.

They performed an inclusive analysis in the global ARROS-1 Phase 1 study (NCT05118789), which enrolled patients with heavily pretreated advanced/metastatic ROS1+ solid tumors. The study aimed to identify the recommended Phase 2 dose (RP2D) and assess both safety and efficacy, using RECIST 1.1 criteria and investigator assessments.

About 104 patients (99 with NSCLC, 5 with other cancers) received zidesamtinib (25-150 mg orally once daily [QD]) in Phase 1. Patients had a median of 3 prior anticancer therapies (range: 1-11), including any ROS1 TKI (99%); lorlatinib (55%), repotrectinib (repo; 21%), or either (67%); ≥2 ROS1 TKIs (69%); and chemotherapy (66%). A history of CNS metastases was present in 53% of patients.

The RP2D of 100 mg QD was selected, with no observed dose relationships for safety or efficacy. No dose-limiting toxicity or treatment-related adverse event (TRAE) led to discontinuation. TRAE resulted in dose reduction in 5.8% of cases. The most common TRAEs were peripheral edema (18%) and transaminase increase (12%); TRAEs were grade ≥3 in 7.7%.

Among 73 patients with ROS1+ NSCLC who were evaluable for response, the overall response rate (ORR) in those with known ROS1 G2032R was 65% (11/17) with a median duration of response (mDOR) of 15.8 months (range: 6, not evaluable) in repo-naïve patients and 38% (3/8) in repo-pretreated patients.

In patients with measurable intracranial (IC) metastases and ≥2 prior ROS1 TKIs (all having prior lorlatinib and/or repo), the IC ORR was 57% (4/7), and the IC DOR ranged from 1.9+ to 17.3+ months with no IC progression observed.

The study concluded that zidesamtinib demonstrated promising efficacy and durability in patients with pretreated ROS1+ NSCLC, including those with ROS1 resistance mutations like G2032R and CNS metastases. The safety profile was favorable, aligning with its ROS1-selective and TRK-sparing design. Phase 2 enrollment is ongoing with registrational intent for both TKI-naïve and pretreated patients with ROS1+ NSCLC.

The trial was sponsored by AstraZeneca and funded by Nuvalent Inc.

Source: https://cslide.ctimeetingtech.com/esmo2024/attendee/confcal/show/session/105

Clinical Trial: https://clinicaltrials.gov/study/NCT05118789

Besse B, Drilon A.E, Cho B.C, et al. (2024). “Phase I/II ARROS-1 study of zidesamtinib (NVL-520) in ROS1 fusion-positive solid tumours.” Presented at ESMO 2024. (Abstract 1256MO).

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