Efficacy and safety of nivolumab (nivo) monotherapy versus chemotherapy (chemo) in recurrent small cell lung cancer (SCLC): Results from CheckMate 331

Reck, Martin; Vicente, David; Ciuleanu, Tudor; Gettinger, Scott; Peters, Solange; Horn, Leora; Audigier-Valette, Clarisse; Pardo, Núria; Juan-Vidal, O.; Cheng, Ying; Zhang, H.; Shi, Meiqi; Wolf, Juergen; Antonia, Scott; Nakagawa, Kazuhiko; Selvaggi, Giovanni; Baudelet, Christine; Han, Chang; Spigel, David R.

doi:10.1093/annonc/mdy511.004

Cited by 89 publications

(82 citation statements)

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“…[31][32][33][34][35][36] In the recently reported Phase 3 CheckMate-331 trial of nivolumab, a human IgG4 monoclonal antibody against PD-1, 569 SCLC patients relapsed on or following platinum-based chemotherapy were randomised (1:1) to receive either nivolumab (N = 284) or standard second-line chemotherapy (topotecan or amrubicin, N = 285). 37 Results of this study showed that, after 7.0-7.6 months of median follow-up, nivolumab did not yield a significant survival improvement (primary endpoint) compared to the standard chemotherapy arm (7.5 months [95% CI 5.6-9.2] versus 8.4 months [95% CI 7.0-10.0], p = 0.11). This confirms that, at least in a subset of relapsed SCLC patients, chemotherapy is the option of choice.…”

Section: Discussionmentioning

confidence: 77%

Phase 2 study of NAB-paclitaxel in SensiTivE and refractory relapsed small cell lung cancer (SCLC) (NABSTER TRIAL)

et al. 2020

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Background Despite sensitivity to first-line chemotherapy, most small-cell lung cancer (SCLC) patients relapse. In this setting, topotecan demonstrated modest activity with significant toxicity. Paclitaxel was also active. This study was designed to evaluate activity and safety of nab-paclitaxel in relapsed SCLC. Methods In this multicentre prospective Phase 2 trial, patients with refractory or sensitive SCLC progressed to first-line platinum-based chemotherapy received nab-paclitaxel 100 mg/smq on days 1, 8, 15 every 4 weeks up to six cycles, progressive disease or intolerable toxicity. Primary endpoint was investigator-assessed objective tumour response. Secondary endpoints were toxicity, progression-free survival (PFS) and overall survival (OS). Results Of the 68 patients treated, partial response was 8% in the refractory cohort and 14% in the sensitive cohort. Most common toxicities of any grade were fatigue (54%), anaemia (38%), neutropenia (29%), leukopenia (26%) and diarrhoea (21%). Median PFS was similar in both refractory (1.8 months) and sensitive cohorts (1.9 months), while median OS was longer in sensitive one (6.6 versus 3.6 months). Conclusions Although nab-paclitaxel has shown some modest anti-tumour activity in relapsed SCLC, associated with a favourable toxicity profile, the primary end-point of the study was not met. Clinical Trial registration Clinical Trial registration number is ClinicalTrials.gov Identifier: NCT03219762.

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Section: Discussionmentioning

confidence: 77%

Phase 2 study of NAB-paclitaxel in SensiTivE and refractory relapsed small cell lung cancer (SCLC) (NABSTER TRIAL)

et al. 2020

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“…Immunotherapy with immune checkpoint inhibitors has demonstrated modest activity in relapsed SCLC patients (nivolumab +/− ipilimumab, pembrolizumab, atezolizumab, and durvalumab + tremelimumab) without clear predictive biomarker identification; and the only phase 3 study carried out comparing nivolumab vs standard chemotherapy (CheckMate 331) was negative [35]. New immunotherapy drugs and combinations remain promising.…”

Section: Systemic Regimens For Es-sclc First Linementioning

confidence: 99%

SEOM clinical guidelines for the treatment of small-cell lung cancer (SCLC) (2019)

et al. 2020

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Small-cell lung cancer (SCLC) accounts for 15% of lung cancers. Only one-third of patients are diagnosed at limited stage. The median survival remains to be around 15-20 months without significative changes in the strategies of treatment for many years. In stage I and IIA, the standard treatment is the surgery followed by adjuvant therapy with platinum-etoposide. In stage IIB-IIIC, the recommended treatment is early concurrent chemotherapy with platinum-etoposide plus thoracic radiotherapy followed by prophylactic cranial irradiation in patients without progression. However, in the extensive stage, significant advances have been observed adding immunotherapy to platinum-etoposide chemotherapy to obtain a significant increase in overall survival, constituting the new recommended standard of care. In the second-line treatment, topotecan remains as the standard treatment. Reinduction with platinum-etoposide is the recommended regimen in patients with sensitive relapse (≥ 3 months) and new drugs such as lurbinectedin and immunotherapy are new treatment options. New biomarkers and new clinical trials designed according to the new classification of SCLC subtypes defined by distinct gene expression profiles are necessary.

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“…Late separation of the survival curves in patients with platinum-resistant SCLC in a second-line study of nivolumab (CheckMate-331) has suggested a potential benefit with immune checkpoint inhibitors used earlier in the disease course of patients with chemotherapy-refractory disease, such as was seen in this patient. 9 TMB and onset of immune-related toxicities are also plausible biomarker candidates relevant to our patient. Given the potential for the previously unseen durability of response and the extension of survival seen in a small, but evolving, subset of patients with advanced SCLC treated with immune checkpoint inhibitors, a more nuanced comparative analysis of these extreme responders is necessary to understand such outcomes and explore strategies to augment their likelihood in an otherwise determinedly recalcitrant disease.…”

Section: Discussionmentioning

confidence: 96%

“…3 Existing and accumulating evidence regarding the use of immune checkpoint inhibitors has suggested that achieving optimal outcomes for these patients will necessitate incorporation of immune checkpoint inhibitors early in the treatment course. Studies of immune checkpoint inhibitors in the maintenance setting (ie, after initial platinum doublet chemotherapy) 7,8 or in the second-line setting 6,9 have failed to show improvements in overall survivalalthough in those patients achieving a response, disease control has generally been more durable than that historically seen with cytotoxic chemotherapy regimens.…”

Section: Discussionmentioning

confidence: 99%

Extensive-Stage Small-Cell Lung Cancer With Sustained Complete Response to Single-Agent Nivolumab and Immune-Related Dermatitis

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Gill

Mantia

et al. 2020

Clinical Lung Cancer

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Efficacy and safety of nivolumab (nivo) monotherapy versus chemotherapy (chemo) in recurrent small cell lung cancer (SCLC): Results from CheckMate 331

Cited by 89 publications

References 0 publications

Phase 2 study of NAB-paclitaxel in SensiTivE and refractory relapsed small cell lung cancer (SCLC) (NABSTER TRIAL)

Phase 2 study of NAB-paclitaxel in SensiTivE and refractory relapsed small cell lung cancer (SCLC) (NABSTER TRIAL)

SEOM clinical guidelines for the treatment of small-cell lung cancer (SCLC) (2019)

Extensive-Stage Small-Cell Lung Cancer With Sustained Complete Response to Single-Agent Nivolumab and Immune-Related Dermatitis

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