Title:
Atezolizumab (Tecentriq®) is accepted for use within NHSScotland
Excerpt:Atezolizumab in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥1% and who have not received prior chemotherapy for metastatic disease.
Evidence Level:Sensitive: A2 - Guideline
Excerpt:Recommendations...Patients with metastatic triple-negative breast cancer with expression of programmed cell death ligand-1 (PD-L1–positive) and no existing contraindications may be offered the addition of immune checkpoint inhibitor to chemotherapy (atezolizumab plus nab-paclitaxel or pembrolizumab plus chemotherapy) as first-line therapy...
Evidence Level:Sensitive: A2 - Guideline
Title:
Atezolizumab with nab-paclitaxel for treating PD-L1-positive, triple-negative, advanced breast cancer
Excerpt:Atezolizumab with nab-paclitaxel is recommended, within its marketing authorisation, for treating triple-negative, unresectable, locally advanced or metastatic breast cancer in adults whose tumours express PD-L1 at a level of 1% or more and who have not had previous chemotherapy for metastatic disease.
Evidence Level:Sensitive: B - Late Trials
Title:
Atezolizumab and pembrolizumab in triple-negative breast cancer: a meta-analysis
Excerpt:For adjuvant therapies, the ORR (OR=1.26, P=0.04) of atezolizumab/pembrolizumab plus chemotherapy was higher in the intention to treat (ITT) arms than the placebo groups in TNBC….We collate evidence of atezolizumab/pembrolizumab as viable therapeutics among patients with TNBC with PD-L1 subgroups deriving higher benefits.
DOI:https://doi.org/10.1080/14737140.2022.2023011
Evidence Level:Sensitive: B - Late Trials
Title:
First-line atezolizumab plus nab-paclitaxel for unresectable, locally advanced, or metastatic triple-negative breast cancer: IMpassion130 final overall survival analysis
Excerpt:...clinically meaningful OS benefit was observed with A + nP in PD-L1 IC-positive patients, consistent with prior interim analyses. This combination remained safe and tolerable with longer follow-up.
DOI:doi.org/10.1016/j.annonc.2021.05.355
Evidence Level:Sensitive: B - Late Trials
Title:
The tumor microenvironment (TME) and atezolizumab + nab-paclitaxel (A+nP) activity in metastatic triple-negative breast cancer (mTNBC): IMpassion130.
Excerpt:Sample classification and PD-L1 distribution are shown (Table). Improved PFS with A + nP vs P + nP was seen in PD-L1 IC+ inflamed and excluded tumors…
DOI:10.1200/JCO.2021.39.15_suppl.1006
Evidence Level:Sensitive: B - Late Trials
Title:
LB162 - Evaluation of tumor immune biomarkers with pathologic complete response (pCR) in patients receiving atezolizumab + chemotherapy in early triple negative breast cancer (eTNBC): exploratory analyses from the IMpassion031 study
Excerpt:PD-L1 expression on IC or TC was linked to numerically increased pCR rates with A + nP-AC.
Secondary therapy:doxorubicin hydrochloride + albumin-bound paclitaxel + cyclophosphamide
Evidence Level:Sensitive: B - Late Trials
Title:
49MO - IMpassion130: Final OS analysis from the pivotal phase III study of atezolizumab + nab-paclitaxel vs placebo + nab-paclitaxel in previously untreated locally advanced or metastatic triple-negative breast cancer
Excerpt:While OS differences for A + nP vs P + nP in the IMpassion130 ITT population were not statistically significant, precluding formal testing, clinically meaningful OS benefit was observed in PD-L1+ pts (7.5-mo median OS improvement).
Evidence Level:Sensitive: B - Late Trials
Title:
Neoadjuvant atezolizumab in combination with sequential nab-paclitaxel and anthracycline-based chemotherapy versus placebo and chemotherapy in patients with early-stage triple-negative breast cancer (IMpassion031): a randomised, double-blind, phase 3 trial
Excerpt:In patients with early-stage TNBC, neoadjuvant treatment with atezolizumab in combination with nab-paclitaxel and anthracycline-based chemotherapy significantly improved pathological complete response rates with an acceptable safety profile.
DOI:10.1016/S0140-6736(20)31953-X
Evidence Level:Sensitive: B - Late Trials
Title:
LBA15 - Primary results from IMpassion131, a double-blind placebo-controlled randomised phase III trial of first-line paclitaxel (PAC) ± atezolizumab (atezo) for unresectable locally advanced/metastatic triple-negative breast cancer (mTNBC)
Excerpt:Of 651 randomised patients, 45% had PD-L1+ mTNBC...Adding atezo to PAC did not improve PFS or OS in either the PD-L1+ or ITT populations….Atezo + PAC did not improve PFS or OS vs placebo + PAC.
Evidence Level:Sensitive: B - Late Trials
Title:
Atezolizumab plus nab-paclitaxel as first-line treatment for unresectable, locally advanced or metastatic triple-negative breast cancer (IMpassion130): updated efficacy results from a randomised, double-blind, placebo-controlled, phase 3 trial
Excerpt:In the exploratory overall survival analysis in patients with PD-L1 immune cell-positive tumours, median overall survival was 25·0 months (95% CI 19·6-30·7) with atezolizumab versus 18·0 months (13·6-20·1) with placebo (stratified HR 0·71, 0·54-0·94]).
DOI:10.1016/S1470-2045(19)30689-8
Evidence Level:Sensitive: B - Late Trials
New
Title:
Atezolizumab and Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer
Excerpt:...among patients with PD-L1-positive tumors, the median overall survival was 25.0 months and 15.5 months, respectively (hazard ratio, 0.62; 95% CI, 0.45 to 0.86). No new adverse effects were identified….Atezolizumab plus nab-paclitaxel prolonged progression-free survival among patients with metastatic triple-negative breast cancer in both the intention-to-treat population and the PD-L1-positive subgroup.
DOI:10.1056/NEJMoa1809615
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer (IMpassion031)
Excerpt:...Percentage of Participants with pCR in Subpopulation with PD-L1-Positive Tumor Status (tumor-infiltrating immune cell [IC] 1/2/3) Using AJCC Staging System...
Evidence Level:Sensitive: C3 – Early Trials
Title:
Real-world ANASTASE study of atezolizumab+nab-paclitaxel as first-line treatment of PD-L1-positive metastatic triple-negative breast cancer
Excerpt:Among them, 21.1% presented de novo stage IV; 78.8% previously received (neo)adjuvant treatment; 55.8% patients had only one site of metastasis; median number of treatment cycles was five (IQR: 3-8); objective response rate was 42.3% (95% CI: 28.9-55.7%)....At 12 months and 24 months, the overall survival rates were 66.3% and 49.1%, respectively....Within the ANASTASE study, patients with PD-L1-positive mTNBC treated with first-line atezolizumab plus nab-paclitaxel achieved PFS and ORR similar to those reported in the IMpassion130 study, with no unexpected adverse events.
DOI:10.1038/s41523-023-00579-2
Evidence Level:Sensitive: C3 – Early Trials
Title:
Atezolizumab and paclitaxel as first line therapy in advanced triple-negative breast cancer patients included in the French early access program
Excerpt:...an early access program (EAP) was opened in France, allowing patients with PD-L1-positive advanced triple negative breast cancer (aTNBC) to receive a combination of paclitaxel and atezolizumab as first line therapy….Median progression-free survival (PFS) and overall survival (OS) were 4.1 months (95% CI [3.0–5.8]) and 17.9 months (95% CI [12.4–NR]), respectively. The 6-months PFS rate was 28% (95% CI [16–40%]) (N = 18/64), while N = 33/64 patients (52%, 95% CI [38–63%]) experienced a tumor response....This real-life study, unique by its setting (EAP granted by anticipation and later withdrawn), suggests atezolizumab and paclitaxel has a limited efficacy in PD-L1-positive aTNBC, especially in patients receiving corticosteroids as comedication before treatment start.
DOI:https://doi.org/10.1038/s41598-023-40569-9
Evidence Level:Sensitive: C3 – Early Trials
Title:
Subgroup analysis of Japanese patients in a phase III randomized, controlled study of neoadjuvant atezolizumab or placebo, combined with nab-paclitaxel and anthracycline-based chemotherapy in early triple-negative breast cancer (IMpassion031)
Excerpt:In the PD-L1-positive population, pathological complete response occurred in 50% (n = 5; 95% confidence interval, 19-81) of patients in the atezolizumab arm and 45% (n = 5; 95% confidence interval, 17-77) in the placebo arm….Atezolizumab added to neoadjuvant chemotherapy numerically improved pathological complete response versus placebo in this small exploratory analysis of Japanese patients with early stage triple-negative breast cancer, a trend directionally consistent with the global study results.
Evidence Level:Sensitive: C3 – Early Trials
Title:
The Degree of Programmed Death-Ligand 1 (PD-L1) Positivity as a Determinant of Outcomes in Metastatic Triple-Negative Breast Cancer Treated With First-Line Immune Checkpoint Inhibitors
Excerpt:In metastatic triple-negative breast cancer (TNBC), the efficacy of immune checkpoint inhibitors (ICIs)...We analyzed six overall survival (OS) curves from three RCTs. In patients with ≥1% positivity, atezolizumab was found to determine a significantly better OS than pembrolizumab. As regards pembrolizumab, adopting a threshold of PD-L1 positivity ≥10% (as opposed to ≥1%) improved median survival to a remarkable extent (23.0 vs 15.5 months).
Evidence Level:Sensitive: C3 – Early Trials
Title:
Atezolizumab and nab-Paclitaxel in Advanced Triple-Negative Breast Cancer: Biomarker Evaluation of the IMpassion130 Study
Excerpt:...evaluated for association with clinical benefit with atezolizumab and nab-paclitaxel (A+nP) vs placebo and nP in unresectable (P+nP) locally advanced or metastatic triple-negative breast cancer....PD-L1 IC+ in either primary or metastatic tumor tissue was linked to progression-free survival and overall survival benefit with A+nP….Although A+nP was more efficacious in patients with richer tumor immune microenvironment, clinical benefit was only observed in patients whose tumors were PD-L1 IC+.
DOI:https://doi.org/10.1093/jnci/djab004
Evidence Level:Sensitive: C3 – Early Trials
New
Title:
Abstract 2859: Inhibition of PD-L1 by MPDL3280A leads to clinical activity in patients with metastatic triple-negative breast cancer (TNBC)
Excerpt:MPDL3280A was generally well tolerated and demonstrated promising efficacy in pretreated metastatic PD-L1 IHC 2 or 3 TNBC pts. Furthermore, circulating biomarker analyses revealed pharmacodynamic responses to MPDL3280A.
DOI:10.1158/1538-7445.AM2015-2859
Evidence Level:Sensitive: C3 – Early Trials
New
Title:
Atezolizumab Plus nab-Paclitaxel in the Treatment of Metastatic Triple-Negative Breast Cancer With 2-Year Survival Follow-up
Excerpt:The PD-L1 expression was centrally evaluated by immunohistochemical analysis...A median of 13 doses (range, 1-64 doses) of atezolizumab and 14 doses (range, 2-80 doses) of nab-paclitaxel were administered….This phase 1b multicohort study assessed atezolizumab plus nab-paclitaxel in 33 patients with advanced triple-negative breast cancer and revealed a manageable safety profile with an objective response rate of 39.4% and durable antitumor responses observed in several patients.
DOI:10.1001/jamaoncol.2018.5152
Evidence Level:Sensitive: C4 – Case Studies
New
Title:
[Effectiveness of Atezolizumab Combination Therapy for PD-L1(SP142)Positive Lung and Breast Double Cancer-A Case Report]
Excerpt:We report a case in which atezolizumab was efficiency in PD-L1 (SP142)-positive lung and breast double cancer...Pretreatment diagnosis was lung adenocarcinoma, cT2a, N2/3, M1b/1c(HEP, OSS), Stage III A/B or IV A/B(PD-L1 positive), and right breast cancer, T4b, N2, M0/1 (HEP, OSS, LYM), Stage III B or IV triple-negative(PD-L1 positive)double cancer. We underwent surgery(mastectomy with axillar lymph nodes dissection), followed by immunochemotherapy(atezolizumab, carboplatin, paclitaxel)and it was efficiency.
Secondary therapy:carboplatin + bisphosphonate bound paclitaxel