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Atezolizumab FDA approved for PD-L1 positive unresectable triple-negative breast cancer

On 8 March 2019, the FDA granted accelerated approval to atezolizumab (Tecentriq®, Genentech/Roche) in combination with albumin-bound paclitaxel (nab-paclitaxel) for the treatment of adult unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) patients with programmed death 1 ligand (PD-L1) stained tumour-infiltrating immune cells (IC) of any intensity covering ≥1% of the tumour area, as determined by the VENTANA PD-L1 (SP142) Assay companion diagnostic (CDx).

U.S. FDA approved immunecheckpoint inhibitors U.S. FDA approved immunotherapies for cancer U.S. FDA approved immunotherapies for cancer

US FDA approved immune-checkpoint inhibitors updated 09-Mar-2019

Know all the United States Food and Drug Administration (U.S. FDA) approved immune-checkpoint inhibitors. Members of MediPaper can download the free PPT slides summarising the U.S. FDA approved immune-checkpoint inhibitors and other U.S. FDA approved immunotherapies.

Immunoncology I-O drugs and immunotherapy for renal cancer RCC

Combinations: upcoming treatment strategies in metastatic renal cell carcinoma

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Prof. Stephen Chan i-o-immunooncology-nivolumab-immunotherapy-hcv-hbv-reactivation-hepatitis-b-hepatitis-c-carrier

I-O in Special Populations: Chronic Viral Hepatitis Carriers

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ESMO 2018 HCC ESMO18 Liver Cancer ESMO2018 hepatocellular carcinoma hepatobiliary cholangiocarcinoma BTC

ESMO 2018 HCC: The ESMO18 hepatobiliary cancer track summarised

Whereas this year’s American Society of Clinical Oncology Annual Meeting (ASCO 2018) boasted two Phase III studies and four Phase II studies with notable results in hepatocellular carcinoma (HCC), the trend did not continue to the European Society for Medical Oncology Conference (ESMO 2018), held in Münich, Germany between October 19-23, 2018. The focus for this years ESMO was mostly on biliary-tract cancers (BTC). Welcome to the hepatobiliary track of ESMO 2018.

Pembrolizumab plus chemotherapy approved for metastatic squamous NSCLC

On October 30th 2018, the FDA approved the use of programmed death 1 (PD-1) inhibitor pembrolizumab (Keytruda®, Merck) in combination with carboplatin plus paclitaxel or nab-paclitaxel for the first-line treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC).

IMpower133 first-line atezolizumab plus chemotherapy in extensive-stage small-cell lung cancer

IMpower133: first-line atezolizumab plus chemotherapy in extensive-stage small-cell lung cancer

Atezolizumab (Tecentriq®, Roche/Genentech) plus standard chemotherapy for the first-line treatment of extensive-stage small-cell lung cancer (SCLC) was associated with a significantly longer overall survival (OS) and progression-free survival (PFS) when compared with chemotherapy alone.

Pembrolizumab plus chemotherapy effective in squamous NSCLC

Pembrolizumab plus chemotherapy effective in squamous NSCLC

Pembrolizumab (Keytruda®, Merck) in combination with chemotherapy was associated with longer overall survival (OS) and progression-free survival (PFS) when compared to placebo plus chemotherapy in patients with untreated metastatic squamous cell non-small cell lung cancer (NSCLC).

JAVELIN Lung 200 avelumab vs docetaxel in patients with pretreated advanced non-small cell lung cancer NSCLC

JAVELIN Lung 200: avelumab vs docetaxel for pretreated NSCLC

Avelumab (Bavencio®, Merck KGaA) does not improve the overall survival (OS) in non-small cell lung cancer (NSCLC) patients previously treated with platinum-doublet chemotherapy, as resulted from the JAVELIN Lung 200 study (NCT02395172). The safety profile favoured avelumab over docetaxel.

Front-line atezolizumab plus chemotherapy improves PFS in NSCLC

Frontline atezolizumab plus chemotherapy improves PFS in NSCLC

An interim analysis of the Phase III IMpower132 study showed that atezolizumab (Tecentriq®, Roche/Genentech) plus platinum-based chemotherapy (cisplatin or carboplatin) with pemetrexed improves the median progression-free survival (PFS) in treatment-naïve patients with non-squamous non-small cell lung cancer (NSCLC). The median PFS for atezolizumab plus pemetrexed and a platinum salt was 7.6 months vs 5.2 months with chemotherapy alone (HR=0.60, 95% CI: 0.49-0.72; p<0.0001).

Prof Stefan Kasper on I-O in EXTREME-ineligible Head and Neck Cancer I-O in SCCHN with focus on EXTREME-ineligible Patients and the future directions of combination immunotherapy

Prof Stefan Kasper on I-O in EXTREME-ineligible SCCHN

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I-O in Special Populations: the Treatment of Immunotherapy-Induced Pneumonitis

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Blood-based TMB-assay predicts response to atezolizumab in NSCLC patients

Plasma TMB predicts response to atezolizumab in NSCLC patients

A high tumour mutational burden in the plasma (bTMB) is a clinically actionable biomarker for atezolizumab (Tencentriq®, Roche) treatment in patients who failed 1st-line platinum-based therapy for advanced non-small cell lung cancer (NSCLC).

Pembrolizumab and atezolizumab USPIs updated by FDA

On the 16th of August, 2018, the FDA updated the prescribing information for pembrolizumab (Keytruda®, Merck) and atezolizumab (Tecentriq®, Roche/Genentech) and added the requirement for the use of an FDA-approved companion diagnostic test (CDx) to determine PD-L1 levels in cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma.

Nivolumab FDA approved for patients with metastatic small cell lung cancer (SCLC)

On the 16th of August 2018, the FDA granted accelerated approval to nivolumab (Opdivo®, Bristol-Myers Squibb) for use in patients with metastatic small cell lung cancer (SCLC) who progressed after two lines of therapy, including one line of platinum-based chemotherapy.

Pembrolizumab plus pemetrexed-platinum approved for use in the 1st-line treatment of metastatic non-squamous NSCLC

Pembrolizumab plus pemetrexed-platinum FDA approved for first-line treatment of metastatic non-squamous NSCLC

On 20th of August 2018, the FDA granted regular approval for pembrolizumab (Keytruda®, Merck) plus pemetrexed and a platinum salt in the first-line treatment of patients with metastatic, non-squamous non-small cell lung cancer (NSCLC), not harbouring any EGFR or ALK genomic tumour aberrations.

CheckMate 032 Nivolumab ipilimumab metastatic esophagogastric cancer

CheckMate 032: Nivolumab +/- ipilimumab for metastatic esophagogastric cancer

Immunotherapy with either nivolumab (Opdivo®, Bristol-Myers Squibb) alone or the combination nivolumab plus ipilimumab (Yervoy®, Bristol-Myers Squibb) in patients with chemotherapy-refractory esophagogastric cancer leads to durable responses and encouraging long-term overall survival with a manageable safety profile, concluded the investigators of the CheckMate 032 study. 

EBV, MSI, and CPS predict pembrolizumab outcome in gastric cancer

Metastatic gastric cancer (mGC) patients with microsatellite instability-high (MSI-H) or Epstein-Barr virus (EBV)-positive tumours, or those with a positive (≥1%) combined positive score (CPS) respond best to pembrolizumab PD-1 immunotherapy.

FDA  has limited the use of Tecentriq and Keytruda for patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing therapy.  More Information.  June 19, 2018

FDA limits use of atezolizumab and pembrolizumab in urothelial carcinoma

On June 19, the FDA limited the use of atezolizumab and pembrolizumab for the treatment of locally advanced or metastatic urothelial cancer patients ineligible for cisplatin-containing therapy.

ASCO 2018 Breast Cancer: The ASCO18 breast cancer track summarised

Breast cancer: a front-runner when it comes to the development of novel therapeutic strategies. With the advent of newer targeted- and immunotherapies, oncologists have an increment of options to offer their patients. The American Society of Clinical Oncology’s (ASCO) 2018 Breast Cancer track offered an extensive look at the latest advancements and updates from on-going trials covering the various subtypes of breast cancer.

FDA approved pembrolizumab for chemotherapy-refractory r/m cervical cancer with PD-L1 CPS ≥1 

 

ASCO 2018 HCC: The ASCO18 hepatocellular cancer track summarised

This year’s American Society of Clinical Oncology (ASCO) annual meeting includes two Phase III studies in the second-line treatment of the disease. Moreover, data with several immune-checkpoint inhibitors were presented, including the KEYNOTE-224 with pembrolizumab. Welcome to the summary of the ASCO 2018 HCC track.

FDA safety alert: use of immunotherapy in metastatic urothelial cancer with low PD-L1 expression

On May 18, the United States (US) Food and Drug Administration (FDA) issued an alert about the decreased survival in studies with pembrolizumab (Keytruda®) and atezolizumab (Tecentriq®) as single agent first-line therapy for patients with metastatic urothelial cancer (mUCC) and low expression of the programmed death ligand 1 (PD-L1) protein.

AACR 2018: first-line atezolizumab, bevacizumab plus chemotherapy active in non-squamous NSCLC

First-line atezolizumab plus bevacizumab, carboplatin and paclitaxel improves PFS in patients with non-squamous NSCLC. Two presentations on the IMPower150 study by Martin Reck (ELCC 2018) and Mark Socinski (AACR 2018) discussed the frontline addition of atezolizumab to bevacizumab and chemotherapy in different lung cancer subgroups (NCT02366143).

Nivolumab-Ipilimumab Combination: A New Option for TMB-High NSCLC (CheckMate 227)

AACR 2018: First-line nivolumabipilimumab in TMB-high NSCLC with was associated with a more than tripled 1-year progression-free survival (PFS) rate compared to platinum-based chemotherapy in the Phase III CheckMate 227 trial (NCT02477826).

Frontline Combination of Pembrolizumab and Chemotherapy: A New Standard of Care for Non-squamous NSCLC

AACR 2018: Frontline pembrolizumab plus chemotherapy in NSCLC reduces the risk of death by more than 50%. The Phase III KEYNOTE-189 trial combined pembrolizumab (Keytruda®) plus standard of care platinum-based chemotherapy in non-squamous non–small cell lung cancer (NSCLC) without EGFR or ALK genetic aberrations (NCT0278680)

Keynote-042 Keynote-024 pembrolizumab nsclc keytruda nsclc non-squamous squamous PD-L1 expression 1% 20% 50% Tony Mok MD NCT02220894 Pembrolizumab effective in frontline NSCLC with low PD-L1 expression

Pembrolizumab effective in frontline NSCLC with low PD-L1 expression

Pembrolizumab (Keytruda®) as single-agent immunotherapy in the frontline setting of any histology NSCLC with a PD-L1 expression ≥1% was associated with improved overall survival (OS) when compared to platinum-doublet chemotherapy in the KEYNOTE-042.

Herbert Loong on irAEs Immunotherapy (I-O) and New Onset Diabetes or immune-mediated diabetes

I-O in Special Populations: Diabetes and Concomitant Steroids

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Making sense of immunotherapy in NSCLC

Making sense of 1st-line immunotherapy in non-small cell lung cancer (NSCLC)

The expansion of therapeutic options with immunotherapies will reflect a dramatic change in the guidelines for lung cancer, where immunotherapies mostly compete with the use of chemotherapeutic agents. A brief communication on immunotherapies for NSCLC.

FDA approved durvalumab as maintenace for unresectable stage III NSCLC responding to platinum-based chemoradiation therapy

 

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Pembrolizumab approved for advanced gastric cancer

On September 22, 2017, the FDA granted accelerated approval to pembrolizumab (KEYTRUDA, Merck) for use in patients with locally advanced or metastatic, gastric or gastroesophageal junction (GEJ) adenocarcinoma positive for PD-L1 as determined by an FDA-approved companion diagnostic (CDx) and progressing after ≥2 prior systemic therapies, including a fluoropyrimidine– and platinum-containing regimen, and, when appropriate, HER2targeted therapy.

PD-L1 Biomarker for Response DAKO 22C3 - MediPaper Medical Communications

PD-L1 Biomarker: a Comparison of ASCO2016 PD-1 and PD-L1 Data

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ESMO 2016 pembrolizumab data medipaper medical communications

ESMO16 Pembrolizumab data – Download the PPT

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ESMO 2016 durvalumab avelumab tremelimumab data medipaper medical communications

ESMO16 Durvalumab, Avelumab, Tremelimumab Data – Download the PPT

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ESMO 2016 atezolizumab data medipaper medical communications

ESMO16 Atezolizumab data – Download the PPT

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ESMO 2016 nivolumab data medipaper medical communications

ESMO16 Nivolumab data – Download the PPT

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ASCO 2016 Avelumab Durvalumab and Tremelimumab Data - MediPaper Medical Communications

ASCO16 Avelumab, Durvalumab, and Tremelimumab

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asco 2016 atezolizumab data

ASCO16 Atezolizumab (Tecentriq©) Data

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asco 2016 nivolumab medipaper medical communications

ASCO16 Nivolumab (Opdivo©) Data

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asco 2016 pembrolizumab medipaper medical communications

ASCO16 Pembrolizumab (Keytruda©) Data

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