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Thread: Lung cancer immunotherapy advances in the news

  1. #1

    Lung cancer immunotherapy advances in the news

    October 10
    BERLIN — Lung cancer treatment is moving beyond chemotherapy, with Merck & Co setting the pace in a new category of therapies that harness the body’s immune system to fight tumours.

    The American company’s drug, Keytruda, reduced the risk of death or cancer progression by 50 per cent, Merck said, unveiling details of a crucial study at a meeting in Copenhagen of the European Society for Medical Oncology.

    The medicine gave patients an average of 10.3 months before their cancer progressed, compared with six months on chemotherapy. Unlike its competitor, Bristol-Myers Squibb, whose similar drug Opdivo failed in an advanced trial and caused its stock to plunge, Merck selected patients who harboured high levels of a protein that’s thought to predict how well the immune-system drugs will work.

    The results gave Merck a head start — and not just on Bristol-Myers. Roche Holding and AstraZeneca are also in the race for the best new immune therapyy against lung tumours, the most common cancer in the world.

    Doctors will probably start testing patients soon after diagnosis to see whether they’re suited to treatment with Keytruda and can forgo the many side effects of chemotherapy, said Mr Stefan Zimmermann, a chief oncologist at the Cantonal Hospital of Fribourg, Switzerland.

    “The main reaction will actually be relief and renewed hope,” Mr Zimmermann said on Sunday (Oct 9) from the meeting. “We have been waiting for ways to ditch the good old chemotherapy that carries significant toxicity.”

    Much of the battle for dominance in lung immune-oncology drugs thus far has centred on whether patients need to show high levels of a protein called PD-L1 to benefit. Merck’s trial focused on patients whose tumours expressed PD-L1 at least half the time.

    By contrast, Bristol-Myers’s competing therapy, Opdivo, failed a test as a sole treatment for lung cancer after the company included patients with lower levels of PD-L1. But details of the trial unveiled at the conference pointed to lacklustre results even in a narrower group of patients with high PD-L1 levels.

    “PD-L1 assessment has to be part of the standard diagnostic workup,” said Mr Corey Langer, director of the thoracic oncology program at the Abramson Cancer Center at the University of Pennsylvania. “Patients can’t wait for these results.”

    Mr Langer led a smaller trial of Merck’s Keytruda also presented in Copenhagen, which combined the drug with chemotherapy and also let in all patients, no matter their PD-L1 levels. The combination was almost twice as successful at shrinking lung cancer tumours than a standard chemotherapy regimen.

    Roche also presented results showing its immune therapy contender, Tecentriq, helped patients whose lung tumours had already progressed. Tecentriq was approved by regulators in May for advanced bladder cancer, and Roche expects a ruling from the FDA in second-line lung cancer by the end of next week. However, results for newly-diagnosed patients aren’t expected before 2018.

    By then, Mr Fazeli said, investors will be focusing on combination therapies. The first results from two immune therapies used together will probably come next year from AstraZeneca.

    Bristol-Myers is also working on such a combination, with data due out in 2018. Like Merck, Roche is combining its immune-oncology drug with chemotherapy, aiming for approval in 2018.
    Last edited by lancepeace; 05-13-2017 at 01:39 PM.

  2. #2
    Oct. 18, 2016
    Tecentriq (atezolizumab) just gained FDA approval for the treatment of metastatic non-small cell lung cancer (NSCLC) who progressed after a platinum-containing regimen and an FDA-approved targeted therapy for patients with EGFR or ALK abnormalities.

    The approval is based on multiple clinical trials, the largest being the phase 3 OAK trial, which was presented at the 2016 European Society for Medical Oncology (ESMO) Congress. In the study, Tecentriq reduced the risk of death by 26 percent compared with docetaxel in patients with advanced NSCLC following the failure of platinum-based chemotherapy. The median overall survival (OS) was improved by 4.2 months with the PD-L1 inhibitor versus chemotherapy. The survival benefit with Tecentriq was observed regardless of PD-L1 status or histology.

    “Tecentriq is a new option to help people with this type of previously treated metastatic lung cancer, regardless of PD-L1 expression, live longer than chemotherapy,” Sandra Horning, M.D., chief medical officer and head of Global Product Development at Genentech, the developer of Tecentriq, said in a statement. “Tecentriq is the first and only approved cancer immunotherapy designed to target the PD-L1 protein, which may play an important role in the way the medicine works.”

  3. #3

    Keytruda approved for frontline use by FDA


    Keytruda (pembrolizumab) was approved by the U.S. Food and Drug Administration (FDA) for the frontline treatment of metastatic non*–small cell lung cancer (NSCLC) whose tumors have 50 percent or more PD-L1 expression based on an FDA-approved test and who do not harbor EGFR or ALK aberrations.

  4. #4

    FDA approves Keytruda with chemotherapy as first line treatment

    Merck Extends Immunotherapy Lead With Lung Cancer Combination Therapy Approval
    Adam Feuerstein Adam Feuerstein Follow May 10, 2017 5:29 PM EDT

    Merck (MRK) won U.S. approval Wednesday for the use of its immunotherapy Keytruda in combination with chemotherapy to treat patients newly diagnosed with non-small cell lung cancer.

    FDA approvals of immunotherapies used alone to treat various cancers have become almost routine, but the agency's latest affirmative nod to Merck marks the first time that an immunotherapy has been combined with another drug to kill cancer cells more effectively.

    Keytruda is now the only PD-1 or PD-L1 checkpoint inhibitor approved to treat first-line lung cancer either as monotherapy or as part of a combination therapy. Rival pharma companies, including AstraZeneca (AZN) , Roche (RHHBY) and Bristol-Myers Squibb (BMY) , are trying to catch up.

  5. #5

    Durvalumab / Imfinzi

    Phase 3 trials showed durvalumab, under the brand name Imfinzi, significantly reduced the risk of disease worsening or death among patients with stage 3 non-small cell lung cancer who had not progressed after standard treatments.

    AstraZeneca said Imfinzi is the first immuno-oncology medicine to show a “superior” impact on progression-free survival rates in this setting. The company said it will work with regulatory authorities to introduce Imfinzi “as soon as possible”.
    Imfinzi reduced the risk of the disease worsening or death in Stage 3 lung cancer patients who had already undergone chemotherapy with radiation.
    Last edited by lancepeace; 05-13-2017 at 01:29 PM.

  6. #6

    Keytruda plus epacadostat from Incyte

    A combination of the Merck & Co immunotherapy Keytruda and a different type of drug that also helps the immune system fight cancer from Incyte Corp led to a high rate of durable responses in a small, ongoing study of patients with advanced lung cancer, according to data released on Wednesday.

    Incyte shares rose more than 6 percent to $128 in post-market trading, after the data became public.

    Fourteen of 40, or 35 percent, of patients with advanced non-small cell lung cancer (NSCLC) who received Keytruda and Incyte's epacadostat experienced tumor shrinkage of at least 30 percent.

    That is nearly double the overall response rate of about 18-20 percent seen with Keytruda alone in other studies.

    BMO Capital Markets analyst Ian Somaiya, in a research note prior to release of the data, said a response rate of about 24-29 percent with a good safety profile would be viewed favorably.

    Patients in the trial had received prior treatments, such as chemotherapy.

    Twelve of the 14 patients who saw significant tumor shrinkage continued to respond to the therapy, with the longest so far at more than 500 days, indicating potential for long-lasting responses.

    Epacadostat belongs to a new class of experimental drugs called IDO1 inhibitors which block an enzyme that protects tumors from the immune system. Keytruda is one of five approved drugs known as PD-1 or PD-L1 inhibitors that block a different mechanism tumors use to evade detection.

  7. #7
    Wish they could find something that works with small-cell... it seems ALL the work is focused on non-small cell.


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