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Jun 3, 2014

AstraZeneca Touts Its Cancer Pipeline

  • Using the American Society of Clinical Oncology (ASCO) annual meeting in Chicago as a backdrop, AstraZeneca today worked to rebound with investors rattled by Pfizer’s ill-fated takeover attempt, touting its cancer pipeline as growing and headed quickly toward promising results and approvals for compounds in advanced development stages.

    “ASCO 2014 is a pivotal meeting for AstraZeneca,” CEO Pascal Soriot declared. “We have compelling new data on important mid to late stage assets, which clearly demonstrate our potential to transform the way cancer is treated and the right people to move them forward. We remain resolute in our ambition to bring these next-generation cancer medicines to patients as fast as possible.”

    Soriot and AstraZeneca recapped a flurry of clinical news involving five of the company’s cancer compounds, with the company noting that 40 scientific abstracts related to AstraZeneca and subsidiary MedImmune investigational drugs were presented at ASCO.

    Furthest along among the five drugs promoted by Soriot is MEDI4736, the leading molecule in AstraZeneca’s cancer pipeline. The company said it plans to launch a Phase III study investigating a combination of MedImmune’s MEDI4736 in combination with another MedImmune compound, tremelimumab, for patients with non-small cell lung cancer (NSCLC).

    The two compounds are already under study by AstraZeneca in a Phase I dose escalation study in patients with refractory NSCLC.

    Also in a dose escalation study is MEDI4736 alone, an engineered human monoclonal antibody directed against programmed cell death ligand 1 (PD-L1). The compound showed durable clinical activity and tolerability across a range of tumor types in multiple Phase I data sets, AstraZeneca said.

    Those sets include data from a Phase I dose escalation study, in which reduction of tumor burden was seen at multiple dose levels as early as six weeks, and clinical activity was maintained over one year. There was a very low frequency of drug-related serious adverse events, and no dose-limiting toxicities were observed, AstraZeneca said.

    The compound also showed durable clinical activity and tolerability across a range of tumor types in multiple Phase I data sets, AstraZeneca said. Dose-expansion phase data also showed early evidence of clinical activity associated with MEDI4736 in over 300 patients in multiple tumor types. AstraZeneca said the Phase I study results, coupled with the pre-clinical data and validation of this target, supported the company’s recent acceleration of MEDI4736 into Phase III clinical trial

    AstraZeneca also confirmed an enlarged recruitment target for its Phase II study of tremelimumab alone in mesothelioma, making it a registration trial.

    Among small-molecule compounds, AstraZeneca cited data it presented Saturday on AZD9291, which showed strong activity as a once-daily monotherapy, with clinical responses observed in an EGFRm+ population of NSCLC patients who previously failed on EGFR TKIs and also in patients with the T790M resistance mutation.

    According to AstraZeneca, 94% of T790M positive (T790M+) patients saw their tumors shrink or become stable. In addition, 64% of T790M+ patients achieved tumor shrinkage of 30% or more. The most common adverse events were low grade diarrhea rash and nausea.

    Also on Saturday and again today, AstraZeneca presented data from a Phase II study by the NIH’s National Cancer Institute (NCI) investigating the combination of olaparib and cediranib in patients with platinum-sensitive high-grade serous ovarian cancer.

    The data showed that the combination of the two oral drug candidates nearly doubled the time it took for patients’ tumors to progress (progression-free survival) and improved objective response rate (ORR), compared to treatment with olaparib alone.

    NCI plans to advance the combination into Phase III development, a decision AstraZeneca said it supported.

    “This is extremely exciting data and among the longest progression-free survival seen by treatments for patients with platinum-sensitive high-grade serous ovarian cancer. What is even more compelling is that the combination of olaparib and cediranib has the potential to replace chemotherapy,” stated Briggs Morrison, evp and CMO. “We look forward to seeing the combination move into Phase III to further explore the potential benefits for patients who currently have very limited treatment options.”


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