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Racing Merck and Pfizer, Roche readies to file subcutaneous Tecentriq after posting phase 3 data

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Roche has taken the lead in the race to bring subcutaneous checkpoint inhibitors to market in the West, reporting phase 3 results that tee it up to file for approval in the U.S. and the EU.

Source
Fierce Pharma

With Positive Data, Checkpoint Looks to Add Second Indication to BLA

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Checkpoint Therapeutics is prepping for a conversation with the U.S. Food and Drug Administration regarding the potential for a second possible indication for its experimental anti-PD-L1 antibody, cosibelimab, based on positive interim efficacy results in a type of carcinoma.

Source
BioSpace

I-O blockbusters from Merck, BMS and more linked to poor COVID-19 outcomes: study

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In the month ending April 7, 423 cancer patients at Memorial Sloan Kettering Cancer Center were diagnosed with COVID-19, 20% of whom developed serious respiratory symptoms. That in and of itself wasn’t surprising, given that cancer patients are immuno-compromised and therefore face a higher risk of struggling with the virus.

But one trend that emerged among those COVID victims did surprise their MSK oncologists: The risk of poor outcomes was higher among patients who had been treated with drugs that inhibit “checkpoints” such as PD-1 and CTLA-4 so the immune system can recognize and attack cancer, according to a study (PDF) published in Nature Medicine.

Source
Fierce Pharma

A lifesaver with a catch: Powerful new cancer drugs can trigger diabetes — and no one is certain why

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The first two rounds of treatment went off without a hitch. But last November, after receiving a third dose of potent immunotherapy for his skin cancer, Rich Lenihan started to feel tired and weak.

He was urinating constantly, and no amount of water could abate his thirst. A blood test revealed glucose levels that were through the roof.

Lenihan, at age 62, had developed a disease akin to type 1 diabetes — formerly called “juvenile” diabetes — a rare complication of drugs known as checkpoint inhibitors that rev up the body’s immune assault on tumor tissue.

Source
Stat

What causes immuno-oncology drug resistance? 2 research teams uncover clues

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Checkpoint-inhibiting cancer drugs don’t work for as many as half of patients, even when they’re combined with other cancer treatments. Now, two separate research groups have uncovered contributors to immuno-oncology drug resistance, offering insight that could lead to new treatment strategies.

Source
Fierce Biotech

BeiGene Initiates Ph III Trial of PD-1 Inhibitor Tislelizumab + Chemotherapy in Advanced Non-Squamous Non-Small Cell Lung Cancer in China

  • Tislelizumab is a monoclonal antibody PD-1 checkpoint inhibitor
  • BeiGene and Celgene have a global collaboration agreement for the development of  tislelizumab outside of Asia (except Japan)

BeiGene, Ltd. (NASDAQ:BGNE) announced on 7/25/18 that the first patient was dosed in a Phase 3 clinical trial of tislelizumab, an investigational anti-PD-1 antibody, combined with chemotherapy, as a potential first-line treatment in Chinese patients with Stage IIIB or IV non-squamous non-small cell lung cancer (NSCLC).

NeoImmuneTech and Roche Collaborate in Clinical Trial of HyLeukin-7 in Combination with a PD-L1 Checkpoint Inhibitor in Advanced High-Risk Skin Cancers

NeoImmuneTech (NIT), an immunotherapy drug development company focused on advanced cancer treatments, and its parent company Genexine, have entered into an agreement with Roche to enable studies of a combination treatment in three advanced high-risk skin cancer types: melanoma, Merkel cell carcinoma and cutaneous squamous cell carcinoma.

Mirati Therapeutics Announces Positive Results in Immuno-Oncology Combination Trials

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Mirati Therapeutics, Inc. (Nasdaq: MRTX) (the Company or Mirati), On 4/24/18 provided a progress update on its lead development programs and announced updated, positive clinical trial data for sitravatinib, a spectrum selective kinase inhibitor, and mocetinostat, a class I and IV HDAC inhibitor. The Company has been evaluating sitravatinib and mocetinostat in separate Phase 2 clinical trials in combination with checkpoint inhibitor therapy in non-small cell lung cancer (NSCLC) patients whose disease had progressed following prior treatment with a checkpoint inhibitor.

Source
CP Wire

Mirati Therapeutics Announces Positive Results in Immuno-Oncology Combination Trials

Mirati Therapeutics, Inc. (Nasdaq: MRTX) (the Company or Mirati), On 4/24/18 provided a progress update on its lead development programs and announced updated, positive clinical trial data for sitravatinib, a spectrum selective kinase inhibitor, and mocetinostat, a class I and IV HDAC inhibitor. The Company has been evaluating sitravatinib and mocetinostat in separate Phase 2 clinical trials in combination with checkpoint inhibitor therapy in non-small cell lung cancer (NSCLC) patients whose disease had progressed following prior treatment with a checkpoint inhibitor.