CheckMate 141: 1-Year Update and Subgroup Analysis of Nivolumab as First-Line Therapy in Patients with Recurrent/Metastatic Head and Neck Cancer

Gillison, Maura L.; Blumenschein, George R.; Fayette, Jérôme; Guigay, J.; Colevas, A. Dimitrios; Licitra, Lisa; Harrington, Kevin; Kasper, Stefan; Vokes, Everett E.; Even, Caroline; Worden, Francis P.; Saba, Nabil F.; Docampo, Lara Carmen Iglesias; Haddad, Robert I.; Rordorf, Tamara; Kiyota, Naomi; Tahara, Makoto; Monga, Manish; Lynch, Mark; Li, Li; Ferris, Robert L.

doi:10.1634/theoncologist.2017-0674

Cited by 73 publications

(63 citation statements)

References 9 publications

(13 reference statements)

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“…Three studies reported on the same population from the CheckMate‐141 clinical trial. The primary CheckMate‐141 study reported outcomes in 2016 and had two subsequent one and two year follow‐ups. These studies were deemed appropriate for inclusion because they collectively presented a complete dataset on one unique cohort.…”

Section: Resultsmentioning

confidence: 99%

Impact of PD‐L1 expression and human papillomavirus status in anti‐PD1/PDL1 immunotherapy for head and neck squamous cell carcinoma—Systematic review and meta‐analysis

et al. 2019

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Programmed cell death‐1 (PD‐1) pathway inhibition in head and neck squamous cell carcinoma (HNSCC) has demonstrated inconsistent efficacy regarding human papillomavirus (HPV) status and PD‐L1 expression. This study compared outcomes in HNSCC in the context of PD‐L1 and HPV expression. Outcomes: PD‐L1 and HPV expression; overall survival (OS), and tumor response (ORR). 1088 patients received PD‐1/L1 inhibitors. Four methodologies were identified in determining PD‐L1 expression, most commonly using the Dako PD‐L1 IHC 22C3 pharmaDx assay. Using a 1% threshold, ORR was greater for PD‐L1 expressers vs non‐expressers (18.9%, CI 16.1‐21.8 v 8.8% CI 5.3‐13.7, P = 0.009), as was OS at 6 months (60.6%, CI 49.2‐71.4 v 49.0%, CI 39.1‐59.0, P = 0.04) but not at 12 or 18 months. No advantages were identified for HPV expressers. Patients expressing PD‐L1 may have a better tumor response and OS. No impact on survival or response was observed based on HPV status.

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Section: Resultsmentioning

confidence: 99%

Impact of PD‐L1 expression and human papillomavirus status in anti‐PD1/PDL1 immunotherapy for head and neck squamous cell carcinoma—Systematic review and meta‐analysis

et al. 2019

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“…2 In a landmark analysis, the median OS starting week 6 after RECISTdefined progression was 8.4 months for the TBP group and 3.8 months for the NTBP group. In the context of all patients randomized to receive nivolumab in the trial, this translates to an efficacy benefit of treatment beyond progression in 1.3% (3 of 240).…”

Section: Discussionmentioning

confidence: 98%

“…For 9 of the 15 patients with reductions in the target lesion size (60%), the pharynx was the primary site of disease ( Table 1) Among patients receiving TBP with nivolumab, the median OS was 12.7 months (95% CI, 9.7-14.6 months; Fig. 2 In a landmark analysis, the median OS starting week 6 after RECISTdefined progression was 8.4 months (95% CI, 6.6-10.8 months) in the TBP group and 3.8 months (95% CI, 2.1-5.3 months) in the NTBP group (Fig. In the overall intent-to-treat population (including patients in the TBP and NTBP groups as well as those who did not experience RECIST-defined progression), the median OS for nivolumab-treated patients was 7.7 months (95% CI, 5.7-8.8 months; Fig.…”

Section: Efficacymentioning

confidence: 99%

Nivolumab treatment beyond RECIST‐defined progression in recurrent or metastatic squamous cell carcinoma of the head and neck in CheckMate 141: A subgroup analysis of a randomized phase 3 clinical trial

Haddad

Concha-Benavente

Blumenschein

et al. 2019

Cancer

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Background Response patterns with immune checkpoint inhibitors may be different from those with chemotherapy. Therefore, assessment of response to immunotherapy with the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1, could result in premature treatment termination. The randomized, open‐label, phase 3 CheckMate 141 trial (NCT02105636), which evaluated nivolumab in recurrent/metastatic squamous cell carcinoma of the head and neck after platinum therapy, allowed treatment beyond first RECIST‐defined progression (TBP) according to protocol‐specified criteria. Methods In CheckMate 141, patients with RECIST‐defined progression who had a stable performance status and demonstrated clinical benefit without rapid disease progression were permitted to receive TBP with nivolumab at 3 mg/kg every 2 weeks until further progression, which was defined as an additional ≥10% increase in tumor volume. This post hoc analysis evaluated outcomes for patients who received TBP with nivolumab. Results Of 240 patients randomized to nivolumab, 146 experienced RECIST‐defined progression. Sixty‐two of these patients received TBP, and 84 discontinued treatment (no TBP). Among the 60 TBP patients evaluable for response, 15 (25%) had no change in their tumor burden, and 15 (25%) had reductions in target lesion size; 3 patients (5%) had reductions >30%. The median overall survival among TBP patients was 12.7 months (95% confidence interval, 9.7‐14.6 months). No new safety signals were observed with TBP. Exploratory analyses of immune cell biomarkers suggested a potential relationship with initial and TBP responses. Conclusions Tumor burden reduction was noted in a proportion of patients who received TBP with nivolumab in CheckMate 141. Additional research is warranted to identify factors predictive of a TBP benefit in this population.

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“…pembrolizumab and nivolumab) have been proved to be safe and effective [27,28,29]. Furthermore, the phase III randomized KEYNOTE-040 trial testing the efficacy of pembrolizumab versus standard treatment (methotrexate, docetaxel or cetuximab) is ongoing (ClinicalTrials.gov Identifier NCT02252042).…”

Section: Discussionmentioning

confidence: 99%

“…Modern agents (i.e. PD-1-receptor antibodies) have been proved to be safe and effective in patients with recurrent or metastatic SCCHN [27,28,29]. …”

Section: Introductionmentioning

confidence: 99%

Efficacy of Carboplatin/Paclitaxel-Based Radiochemotherapy in Locally Advanced Squamous Cell Carcinoma of Head and Neck

et al. 2018

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Background: Cisplatin-based chemotherapy (CTX) is commonly used concurrently with radiotherapy for head and neck cancer. The value of CTX regimens other than cisplatin for locally advanced squamous cell carcinoma of head and neck (LASCCHN) has not been well established. Here we compare the outcome of patients treated with different platinum-based chemotherapy regimens. Methods: Medical records from 104 patients with LASCCHN treated with radiochemotherapy (RCTX) between February 2013 and August 2016 were analyzed. Results: All patients were treated with intensity-modulated radiation therapy (51 definitive, 53 postoperative). The median total dose was 66.6 Gy and the median fraction dose was 1.8 Gy. 81 (78%) patients were administered cisplatin CTX, 23 (22%) patients received carboplatin and paclitaxel (CarboTaxol). The rate of recurrence was 38% in patients treated with cisplatin and 30% in CarboTaxol-treated patients (p = 0.6). Regarding the CTX regimens, event-free survival (EFS) was 37 versus 30 months (p = 0.6) and overall survival (OS) was 35 versus 28 months (p = 0.5) in cisplatin group versus CarboTaxol group, respectively. Significantly higher grade 3/4 acute toxicity in terms of dysphagia was observed following cisplatin-based RCTX (p = 0.002). In multivariable analysis, females and patients with early primary tumors (T1-2) have longer EFS and OS, regardless the CTX regimen. Conclusions: Primary or adjuvant RCXT with CarboTaxol is a safe and effective treatment alternative for LASCCHN patients with contraindication to cisplatin-based RCTX.

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CheckMate 141: 1-Year Update and Subgroup Analysis of Nivolumab as First-Line Therapy in Patients with Recurrent/Metastatic Head and Neck Cancer

Cited by 73 publications

References 9 publications

Impact of PD‐L1 expression and human papillomavirus status in anti‐PD1/PDL1 immunotherapy for head and neck squamous cell carcinoma—Systematic review and meta‐analysis

Impact of PD‐L1 expression and human papillomavirus status in anti‐PD1/PDL1 immunotherapy for head and neck squamous cell carcinoma—Systematic review and meta‐analysis

Nivolumab treatment beyond RECIST‐defined progression in recurrent or metastatic squamous cell carcinoma of the head and neck in CheckMate 141: A subgroup analysis of a randomized phase 3 clinical trial

Efficacy of Carboplatin/Paclitaxel-Based Radiochemotherapy in Locally Advanced Squamous Cell Carcinoma of Head and Neck

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