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Imfinzi

AstraZeneca scores Japanese approval for Imfinzi combo in extensive-stage small cell lung cancer

AstraZeneca's Imfinzi (durvalumab) has secured approval in Japan for the treatment of extensive-stage small cell lung cancer when combined with etoposide and either carboplatin or cisplatin platinum chemotherapy, it has emerged.

The Japanese Ministry of Health, Labour and Welfare awarded the authorisation based on Phase 3 data which showed that Imfinzi generated “statistically significant and clinically meaningful improvement” in overall survival (OS), meeting its primary endpoint back in June last year.

Two CHMP recommendations for AstraZeneca: Imfinzi in first-line lung cancer, Calquence in chronic lymphocytic leukaemia

AstraZeneca has secured two new recommendations for approval of its products from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP): Imfinzi (durvalumab) and Calquence (acalabrutinib).

Imfinzi received CHMP backing for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) in combination with chemotherapy: etoposide plus either carboplatin or cisplatin. 

FDA immunotherapy first with the approval of AZ's Imfinzi in first-line extensive-stage small cell lung cancer

AstraZeneca has seized FDA approval for its immune checkpoint inhibitor Imfinzi (durvalumab) in the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC).

The approval relates to Imfinzi when used in combination with standard-of-care chemotherapies etoposide plus either carboplatin or cisplatin (platinum-etoposide).

Success and failure at Phase 3 for AstraZeneca's Imfinzi combos in first-line small cell lung cancer

AstraZeneca has pulled back the curtain on new Phase 3 data for Imfinzi (durvalumab) in the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC), showing that the drug demonstrated “sustained, clinically meaningful overall survival (OS) benefit” when combined with a choice of standard-of-care (SoC) chemotherapies.

These data follow findings in June last year which demonstrated the Imfinzi combo’s “significant and clinically meaningful improvement” in OS compared to SoC alone.

Phase 3 failure for AstraZeneca's Imfinzi combo in unresectable metastatic bladder cancer

New Phase 3 has been released by AstraZeneca, showing that the PD-L1 inhibitor Imfinzi (durvalumab), when combined with tremelimumab, failed to meet its primary endpoint in the treatment of unresectable metastatic bladder cancer.

Specifically, the study was investigating the therapy’s efficacy in adult patients in whom over 25% of their tumour cells express PD-L1, or in patients receiving the combo regardless of PD-L1 expression.

China approves AstraZeneca's Imfinzi for advanced non-small cell lung cancer

AstraZeneca’s Imfinzi (durvalumab) is set to be made available in China after the country’s National Medical Products Administration (NMPA) decided to authorise the therapy for the treatment of advanced non-small cell lung cancer (NSCLC).

The approval specifically concerns unresectable, Stage 3 forms of the disease in patients whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (CRT)

FDA gives priority review for AstraZeneca’s Imfinzi

The FDA has granted a priority review of AstraZeneca’s cancer treatment drug Imfinzi (durvalumab) for treatment of patients with untreated small cell lung cancer (SCLC), according to the company.

The move comes after positive results of their Phase 3 CASPIAN trial. The results, recently released in The Lancet journal, showed that there was significant and clinically meaningful improvement in survival rates from the drug.

AstraZeneca's Imfinzi triple combo beats chemo in treatment-naive metastatic lung cancer

AstraZeneca has unveiled positive new Phase 3 data for the combination of Imfinzi (durvalumab) and anti-CTLA4 antibody tremelimumab with chemotherapy in treatment-naïve metastatic non-small cell lung cancer (NSCLC), showing that the therapy met its primary endpoint in the trial.

In a study comparing the efficacy of Imfinzi plus one of five standard-of-care platinum-based chemotherapy options versus chemo alone, the aforementioned combo was shown to generate a “statistically significant and clinically meaningful improvement” in progression-free survival.

AstraZeneca's Imfinzi combo tops chemotherapy in treatment-naive advanced lung cancer

AstraZeneca has unveiled new Phase 3 data for its immunotherapy Imfinzi (durvalumab), showing that it achieved its primary endpoint when combined with four cycles of standard-of-care chemotherapy in the treatment of previously-untreated extensive-stage small cell lung cancer.

The findings showed that the Imfinzi combo reduced the risk of death by 27% with a median overall survival (OS) of 13.0 months versus 10.3 months with SoC, consisting of up to six cycles of chemotherapy and optional prophylactic cranial irradiation (PCI).

AstraZeneca's Imfinzi flops in advanced treatment-naive non-small cell lung cancer

New data have emerged illustrating that AstraZeneca’s anti-CTLA4 antibody Imfinzi (durvalumab) failed to meet its primary endpoint when used in combination with tremelimumab in the treatment of previously-untreated Stage IV (metastatic) non-small cell lung cancer (NSCLC), compared to standard-of-care (SoC) platinum-based chemotherapy.

The study was performed in an all-comers population, with a primary analysis of patients with a high tumour mutational burden (TMB), meaning a higher number of mutations in the tumour’s DNA, potentially making it more visible to the immune system.

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