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bladder cancer

MSD's Keytruda misses the mark at Phase 3 in advanced bladder cancer

MSD has announced the disappointing findings that its anti-PD-1 immunotherapy Keytruda (pembrolizumab), when used either alone or combined with chemotherapy, failed to meet its dual goals at Phase 3 in the first-line treatment of advanced or metastatic urothelial carcinoma.

The company revealed that, in a study of 1,010 participants, the Keytruda plus chemo combo was shown to improve overall survival (OS) and progression-free survival (PFS) rates compared to chemo alone – the study’s two main metrics of success – but this was confirmed to not reach statistical significance.

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.

Seattle Genetics and Astellas unveil positive results for Padcev-Keytruda treatment for bladder cancer

Seattle Genetics and Astellas reported positive results from their trials of Padcev plus Keytruda in treating bladder cancer.

The data from the Phase 2 trial shows that the treatment is meeting “outcome measures for safety and demonstrating encouraging clinical activity.” It was tested on two groups comprising 45 patients.

MSD's Keytruda chalks up bladder cancer approval in the US

MSD’s blockbuster immunotherapy Keytruda (pembrolizumab) has added another US approval to its repertoire with the news that FDA has awarded marketing authorisation to the therapy for the treatment of a specific form of bladder cancer.

Specifically, the ruling was made in regard to patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours who are ineligible for or have elected not to undergo cystectomy.

FDA approves Seattle Genetics and Astellas Pharma’s bladder cancer drug

The FDA has granted accelerated approval for Seattle Genetics and Astellas Pharma’s bladder cancer drug Padcev (enfortumab vedotin-ejfv).

The drug’s most recent results come from a Phase 2 trial that contained 125 patients with locally advanced or metastatic urothelial cancer.

NICE rejects Keytruda for routine use in NHS bladder cancer treatment

The National Institute for Health and Care Excellence (NICE) has given an initial ‘no’ for Keytruda’s (pembrolizumab) use in treating bladder cancer through the NHS.

The immunotherapy is currently available as a treatment option on the NHS through the Cancer Drugs Fund, and will continue to be until at least January 2020 when NICE will review its initial decision.

Roche's Tecentriq meets primary endpoint in Phase 3 bladder cancer trial

Roche has said its immunotherapy drug Tecentriq (Atezolizumab), when used in combination with platinum-based chemotherapy, significantly reduced the risk of disease worsening and death in a Phase 3 trial of patients with bladder cancer.

Roche’s immunotherapy, in combination with chemotherapy, met its primary endpoint in the IMvigor130 Phase 3 trial after significantly reducing the chance of disease worsening or death in people with previously untreated, locally advanced or metastatic urothelial carcinoma (mUC) compared with chemotherapy alone.

Scientists use cold virus to treat bladder cancer

A strain of the virus that causes the common cold has been found to potentially target, infect and kill cancer cells, according to researchers from the University of Surrey.

In a study published in the journal Clinical Cancer Research, scientists investigated the safety and tolerability of exposure to the oncolytic (cancer killing) virus coxsackievirus (CVA21), a naturally occurring strain of the common cold virus.

Janssen's Balversa becomes first FDA-approved FGFR kinase inhibitor for advanced bladder cancer

Janssen’s Balversa (erdafitinib) has become the first FDA-approved fibroblast growth factor receptor (FGFR) kinase inhibitor after the US agency authorised the therapy for the treatment of advanced bladder cancer.

Specifically, the approval covered the use of the drug in locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 or FGFR2 genetic alterations in patients whose disease has progressed following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

Clovis Oncology discontinue phase 2 bladder cancer trial

Colorado-based pharma firm Clovis Oncology has said in a filing to the US Securities and Exchange Commission that it is discontinuing the phase 2 ATLAS trial of Rubraca (rucaparib) monotherapy in recurrent metastatic bladder cancer.

The decision was based on indications from an independent data monitoring committee. The review of preliminary data from 62 patients found the treatment “may not provide a meaningful clinical benefit.” The decision was not based on safety concern, Clovis said.

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