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Frontline atezolizumab plus bevacizumab and chemotherapy FDA approved for metastatic non-squamous NSCLC

On 6 December 2018, the FDA approved atezolizumab (Tecentriq®, Roche/Genentech) plus bevacizumab and chemotherapy with paclitaxel and carboplatin for the frontline treatment of metastatic non-squamous non-small cell lung cancer (NSq NSCLC) patients not harbouring any EGFR or ALK genomic tumour aberrations.

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 11-Dec-2018

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.

Lorlatinib FDA approved for metastatic ALK-positive NSCLC

On November 2nd 2018, lorlatinib (LORBRENA®, Pfizer) received accelerated approval by the FDA for the second- and third-line treatment of patients with metastatic, anaplastic lymphoma kinase (ALK)-positive, non-small cell lung cancer (NSCLC). Third-line patients should have had progression on crizotinib and another ALK-inhibitor for metastatic disease, and second-line patients should have had progression on either alectinib or ceritinib in the first-line for metastatic disease.

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).

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).

Brigatinib prolongs PFS compared to crizotinib in ALK-Positive NSCLC

Brigatinib prolongs PFS compared to crizotinib in ALK-Positive NSCLC

Brigatinib (Alunbrig®, Ariad) significantly prolongs the progression-free survival (PFS) in anaplastic lymphoma kinase (ALK) inhibitor-naïve patients with ALK-rearranged non-small cell lung cancer (NSCLC) when compared to crizotinib, as resulted from the ALTA-1L study.

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.

Dacomitinib FDA approved for the first-line treatment of metastatic EGFR-mutated NSCLC

On September 27, 2018, the FDA approved dacomitinib (Vizimpro®, Pfizer) as first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) harbouring epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or exon 21 L858R mutations as confirmed by an FDA-approved test.

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).

First-line osimertinib vs EGFR-TKI in Asian patients with advanced NSCLC

First-line osimertinib vs EGFR-TKI in Asian patients with advanced NSCLC

First-line osimertinib was associated with a clinically meaningful progression-free survival (PFS) improvement when compared to a standard-of-care (SOC) epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI) in a sub-analysis of Asian patients who participated in the FLAURA trial (NCT02296125).

Capmatinib plus gefitinib promising in MET-dysregulated NSCLC

The combination capmatinib (INC280, Novartis) plus gefitinib (Iressa®, AstraZeneca) showed promising, early phase efficacy in patients with mesenchymal-epithelial transition factor (MET)-dysregulated and epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).

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).

First-in-Class Oncology Vaccine BIL06v Starts Phase 1 Evaluation

Biosceptre has announced the initiation of its Phase 1 clinical study with the peptide vaccine BIL06v. BIL06v is a peptide-protein conjugate that recruits the patient’s immune system to make antibodies specifically targeted at nfP2X7-expressing cancer cells resulting in tumour cell death.

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.

Pan-EGFR TKI pirotinib has commenced into Phase II clinical testing in China

HONG KONG, CHINA – 13 August 2018 – Sihuan Pharmaceutical Holdings Group Ltd. (HKEx: 0460), announced that its innovative in-house developed oncology drug pirotinib has commenced into Phase II Clinical testing in China following the completion of a Phase I clinical trial in three renowned cancer research centres in the United States. 

Osimertinib in patients with T790M-positive advanced non-small cell lung cancer and brain metastases (AURA3)

Osimertinib is active in the second-line treatment of patients with T790M-positive advanced non-small cell lung cancer (NSCLC) and central nervous system (CNS) metastases, as reported by the investigators of the Phase III AURA3 study.

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).

FDA approved osimertinib for the 1st-line treatment of patients with EGFR exon 19 deletions or exon 21 L858R mutations positive metastatic non-small cell lung cancer (NSCLC)

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FDA approved osimertinib (Tagrisso, AstraZeneca Pharmaceuticals LP) for the 1st-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.

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.

Crizotinib beneficial for East-Asian NSCLC-patients with ROS1 alterations crizotinib asian crizotinib ros1 crizotinib asian nsclc patients crizotinib asian non-small cell lung cancer patients

Crizotinib beneficial for East-Asian NSCLC patients with ROS1 alterations

Crizotinib in Asian NSCLC patients with ROS1 alterations was associated with a 71.7% objective response rate (ORR) with a median duration of response (DOR) of 19.7 months (95% CI, 14.1 months – not reached). Learn more about the results with crizotinib in East-Asian non-small cell lung cancer (NSCLC) patients harbouring c-ros oncogene 1 (ROS1) rearrangements.

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

 

FDA approved a broadened indication of afatinib in the 1st-line treatment of metastatic NSCLC with non-resistant EGFR mutations