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Association details:
| Biomarker: | PD-L1 expression |
|---|---|
| Cancer: | Lung Non-Small Cell Squamous Cancer |
| Drug: | Keytruda (pembrolizumab) (PD1 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
NICE Recommends MSD’s KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy for Routine Commissioning for First-Line Treatment of Adults with Untreated Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)
Published date:
01/07/2022
Excerpt:
MSD (Merck Sharp & Dohme) (tradename of Merck & Co., Kenilworth, N.J., USA (NYSE:MRK)) is proud to announce that the National Institute for Health and Care Excellence (NICE) has issued a final appraisal determination (FAD) that recommends pembrolizumab when used in combination with carboplatin and paclitaxel as an option for untreated metastatic squamous non-small-cell lung cancer (NSCLC) in adults....The recommendation is based on data from the Keynote 407 trial (559 adults)....The overall survival benefit was consistent regardless of the level of PD-L1 expression.
Secondary therapy:
carboplatin + paclitaxel
Source:
Published date:
02/16/2021
Excerpt:
PD-L1 expression positive (≥1%-49%)…squamous cell carcinoma…Useful in certain circumstances...Pembrolizumab (category 2B)
Source:
Published date:
02/16/2021
Excerpt:
PD-L1 expression positive (≥1%-49%)…squamous cell carcinoma…Preferred…Carboplatin + (paclitaxel or albumin-bound paclitaxel) + Pembrolizumab (category 1)
Secondary therapy:
carboplatin + bisphosphonate bound paclitaxel; carboplatin + albumin-bound paclitaxel
Source:
Title:
KEYNOTE - 407 China Extension Final Analysis: Pembrolizumab Plus Chemotherapy for the Treatment of Metastatic Squamous NSCLC
Published date:
08/18/2021
Excerpt:
125 patients were randomized; 65 to pembrolizumab + chemotherapy and 60 to placebo + chemotherapy….Pembrolizumab + chemotherapy as first-line treatment improved OS and PFS with durable long-term benefit compared with placebo + chemotherapy in patients with squamous NSCLC, regardless of PD-L1 expression...
Secondary therapy:
carboplatin + paclitaxel
Trial ID:
Source:
Title:
Pembrolizumab plus Chemotherapy for Squamous Non–Small-Cell Lung Cancer
Excerpt:
559 patients with untreated metastatic, squamous NSCLC to receive...pembrolizumab or saline placebo...the patients also received carboplatin and either paclitaxel or nanoparticle albumin-bound [nab]–paclitaxel...the median progression-free survival was 6.4 months (95% CI, 6.2 to 8.3) in the pembrolizumab-combination group and 4.8 months (95% CI, 4.3 to 5.7) in the placebo-combination group (hazard ratio for disease progression or death, 0.56; 95% CI, 0.45 to 0.70; P<0.001) (Figure 2A)....The progression-free survival benefit of the pembrolizumab combination was observed in all prespecified subgroups (Figure 2B), with incremental improvements noted with increasing PD-L1 tumor proportion score (median progression-free survival among patients with a PD-L1 tumor proportion score of <1% in the pembrolizumab-combination group vs. the placebo-combination group....Prolongation of overall survival of a consistent magnitude was observed across the categories of PD-L1 tumor proportion score (<1%, 1 to 49%, and ≥50%)...
Secondary therapy:
carboplatin + albumin-bound paclitaxel; carboplatin + paclitaxel
DOI:
10.1056/NEJMoa1810865
Trial ID:
Excerpt:
Keytruda as monotherapy is indicated for the first line treatment of metastatic non small cell lung carcinoma in adults whose tumours express PD L1 with a ≥ 50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations.
Source:
Title:
Phase II randomized, open, controlled trial for PD-1 monoclonal antibody combined with platinum-containing chemotherapy versus PD-1 monoclonal antibody for first-line treatment of recurrent or advanced metastatic non-small cell lung cancer with positive PD-L1 expression
Excerpt:
...Patients with positive EXPRESSION of PD-L1 (TPS>=1%) who were provided with detectable tissue samples before enrollment and confirmed by the central laboratory; 6. ...
Trial ID:
Source:
Title:
KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Advanced Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)
Excerpt:
...Programmed Cell Death-Ligand 1 (PD-L1) Tumor Expression Level: Tumor Proportion Score (TPS) ...
Trial ID:
More C2 evidence
Source:
Title:
PEmbRolizumab verSus chEmotherapy and pEmbrolizumab in Non-small-cell Lung Cancers (NSCLC) With PDL1 ≥ 50 %
Excerpt:
...PD-L1 expression on ≥ 50 % of tumor cells, which will be determined locally....
Trial ID:
Source:
Title:
Personalized Therapeutic Anti-tumor Vaccine With Pembrolizumab and Standard of Care Chemotherapy in Squamous Non-Small Cell Lung Cancer and Extensive Stage Small Cell Lung Cancer
Excerpt:
...- Sufficient tumor tissue must be available for histologic assessment of PD-L1 expression and for sequence and immunological analysis....
Trial ID:
Source:
Title:
Clinical Study of Ivonescimab for First-line Treatment of Metastatic Squamous NSCLC Patients
Excerpt:
...- Tumor Proportion Score (TPS) with PD-L1 expression percent...
Trial ID:
Source:
Title:
Low-Dose Interleukin-2 and Pembrolizumab for the Treatment of Stage IV Non-Small Cell Lung Cancer
Excerpt:
...Patients must have tumor PD-L1 expression of ≥1% (by 22c3 PD-L1 companion testing); patients whose PD-L1 status could...
Trial ID:
Source:
Title:
Study of Pembrolizumab Maintenance Following First-Line Platinum Based Chemotherapy in Patients With Metastatic Squamous - Non-Small Cell Lung Cancer (sNSCLC)
Excerpt:
...overall response rate (ORR)`overall survival`PD-L1 expression in tumor samples`Safety (adverse events graded according to US NCI Common terminology criteria for adverse events)`Functional Assessment of Cancer Therapy for patients with Lung cancer`Lung Cancer Symptom Scale (LCSS)...
Trial ID:
Less C2 evidence
Source:
Title:
First-Line Pembrolizumab Plus Chemotherapy for Advanced Squamous NSCLC: Real-World Outcomes at U.S. Oncology Practices
Published date:
12/06/2022
Excerpt:
...we selected adult patients with newly diagnosed or recurrent advanced squamous NSCLC...who initiated first-line pembrolizumab-chemotherapy....Median OS was 15.3 months (95% CI: 11.7-18.6), with 12- and 24-month OS rates of 54.9% and 37.3%, respectively. Median OS did not differ with PD-L1 expression: 16.2 months (95% CI: 10.3-20.6) for PD-L1 greater than or equal to 1% and 17.2 months (95% CI: 10.8-20.6) for PD-L1 less than 1%.
Secondary therapy:
Chemotherapy
DOI:
10.1016/j.jtocrr.2022.100444
Title:
Pembrolizumab Plus Chemotherapy for Chinese Patients With Metastatic Squamous NSCLC in KEYNOTE-407
Excerpt:
Patients enrolled from mainland China in the KEYNOTE-407 global (NCT02775435) and China extension studies (NCT03875092) were randomized 1:1 to 35 cycles of pembrolizumab or placebo plus four cycles of carboplatin and paclitaxel or nab-paclitaxel….Two-year OS and PFS rates for pembrolizumab–chemotherapy versus placebo–chemotherapy were 56.9% versus 31.7% and 24.2% versus 3.3%, respectively....HRs for OS favored pembrolizumab–chemotherapy across most patient subgroups, including patients with PD-L1 TPS greater than or equal to 1% and PD-L1 TPS less than 1% (Fig. 2B).
Secondary therapy:
carboplatin + albumin-bound paclitaxel; carboplatin + paclitaxel
DOI:
https://doi.org/10.1016/j.jtocrr.2021.100225
Trial ID:
