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May 16, 2013

Pharma Touting Phase II/III Wins in Run-Up to ASCO

  • The run-up to this year’s American Society of Clinical Oncology meeting has several biopharma firms promulgating late-stage clinical results.

    Amgen, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, and Roche/Genentech are among those companies announcing clinical oncology achievements ahead of the annual meeting, to be held later this month in Chicago.

    Presenting preliminary results of three analyses of Vectibix® (panitumumab) in combination with FOLFOX as a first-line treatment for metastatic colorectal cancer, Amgen today said it has identified biomarkers predictive of response to the former drug. The firm said that activating mutations in KRAS (beyond exon 2) and mutations in NRAS—collectively, RAS—are predictive of Vectibix response. “The identification of new biomarkers may further help to identify appropriate patients with this incurable disease for such treatment,” Sean Harper, Amgen R&D evp, said in a statement.

    In a predefined retrospective subset analysis of its Phase III PRIME study, Amgen found that patients with mutant RAS tumor status had inferior progression-free survival when administered Vectibix with FOLFOX, compared with FOLFOX alone. In a separate analysis from the same trial, the company found an improvement in overall survival among patients with wild-type KRAS exon 2 metastatic colorectal cancer treated with the Vectibix-FOLFOX combination.

    Meantime, Roche’s Genentech is reporting Phase III successes for its investigational drug GA101 for the treatment of chronic lymphocytic leukemia (CLL). Presenting results from its CLL11 trial conducted in collaboration with the German CLL Study Group, Roche said that GA101 combined with chlorambucil demonstrated a significant 86% reduction in the risk of disease progression, relapse, or death among CLL patients studied. Further, the company said that median progression-free survival more than doubled—to 23 months from 10.9 months—among patients administered the GA101-chlorambucil combination compared with chlorambucil alone.

    Explained Pablo Umaña, head of Roche Glycart, in a statement: “With GA101, our aim was to design a unique antibody that kills cancer cells directly and engages the patient’s own immune cells to help attack the cancerous cells.” Roche added that it will be presenting further trial data at the upcoming meeting.

    Boehringer Ingelheim will be presenting data from its Phase III studies on afatinib and nintedanib in two populations of patients with advanced non-small-cell-lung cancer (NSCLC) in Chicago this month. The firm today said that afatinib, which was evaluated in the LUX-Lung 6 trial as a first-line treatment in Asian patients with EGFR mutation-positive advanced NSCLC, has met its primary endpoint, extending media progression-free survival. Boehringer added that nintedanib, studied in combination with chemotherapy in the LUME-Lung 2 trial as a second-line treatment in patients with advanced NSCLC after first-line initial chemotherapy had failed, also showed improvements in median progression-free survival as compared with chemotherapy alone.

    In a statement, Mathias Knecht, vp of Medical and Regulatory Affairs, said his firm’s “positive study results support why it’s important to explore tailored treatment options.”

    AstraZeneca, too, will be presenting clinical trial data at ASCO, specifically from a Phase II study on olaparib, the company’s investigational PARP inhibitor. In a statement, the company said that olaparib showed potential as a maintenance treatment for platinum-sensitive relapsed ovarian cancer patients with BRCA gene mutations. AstraZeneca added that it plans to move the drug into Phase III trials during the second half of this year.

    Additionally, AstraZeneca is slated to present data from a Pohase II trial of selumetinib, a selective MEK kinase inhibitor, in patients with advanced uveal melanoma. The firm also announced separate plants to move the drug into a Phase III trial evaluating selumetinib plus docetaxel as a second-line therapy for patients with KRAS mutation-positive, metastatic NSCLC, also during the second half of this year.

    Elsewhere, Bristol-Myers Squibb will be presenting five-year survival results from four Phase II trials evaluating its Yervoy® (ipilimumab) in patients with metastatic melanoma, the company said. Further, the firm will also present Phase II safety and efficacy results on elotuzumab plus lenalidomide and low-dose dexamethasone in patients with relapsed multiple myeloma, along with partner AbbVie.

    And Gilead Sciences also announced results from a Phase II study, a trial evaluating its investigational PI3K delta inhibitor idelalisib in combination with rituximab for older patients with treatment-naïve CLL. Gilead said patients treated with the idelalisib-rituximab combination achieve a complete response rate of 19% and an overall response rate of 97%, with an estimated 93% progression-free survival rate at 24 months.

    Gilead Sciences

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