ASCO Highlights Include Phase III Findings in Multiple Tumor Types

Anita T. Shaffer @Shaffer1
Published: Wednesday, May 27, 2015

Emerging Agents Showcased

While Puma Biotechnology’s experience provides a dramatic example of the ways in which ASCO abstracts can affect a company’s prospects in the marketplace, the conference offers an opportunity for pharmaceutical developers throughout the world to shine a spotlight on their research programs.

In addition to the late-stage clinical trial findings that Kantar cited, there are many studies that are expected to help physicians determine optimal uses for established and emerging compounds. Here are some of the agents that oncology thought leaders, analysts, and the companies themselves consider noteworthy:

  • MEDI4736—Safety and efficacy data will be reported from a clinical trial in which the PD-1 inhibitor is paired with tremelimumab, which targets CTLA-4, in patients with NSCLC (Abstract 3014). AstraZeneca, which is developing the drug through its MedImmune research arm, has obtained a fast-track designation from the FDA for MEDI4736 as monotherapy for patients with advanced NSCLC.
  • Daratumumab—Results from the phase II Sirius study of daratumumab monotherapy in patients with multiple myeloma who have received ≥3 lines of prior therapy or whose disease is double refractory to a proteasome inhibitor and an immunomodulatory drug will be presented in a late-breaking abstract (Abstract LBA8512). Johnson & Johnson, which is partnering with Genmab through its Janssen Biotech division to develop the drug, has told investors that the findings would support a new drug application in the United States and Europe this year, according to FirstWord Pharma. The FDA has designated daratumumab as a breakthrough therapy in this setting.
  • Pembrolizumab (Keytruda)—Findings about Merck’s PD-1 inhibitor will be reported across a broad range of tumor types in approximately a dozen abstracts, with notable results expected in advanced squamous cell carcinoma of the head and neck (LBA6008) and in the potential for the use of mismatch repair deficiency as a biomarker for response to the therapy in multiple tumor types (LBA100).
  • Avelumab—Updates on early clinical trial data will be provided for this PD-L1 inhibitor in metastatic or locally advanced solid tumors, recurrent ovarian cancer, and NSCLC (Abstracts 3044, 5509, and 8034). Merck Serona and Pfizer are collaborating on the development of this agent.
  • Afatinib (Gilotrif)—The overall survival analysis of the LUX-Lung 8 phase III trial of this EGFR inhibitor versus erlotinib (Tarceva) as second-line therapy for patients with advanced squamous cell carcinoma will be presented, along with data about patient-reported outcomes (Abstracts 8002 and 8100). The EGFR inhibitor, which Boehringer Ingelheim is developing, is approved for patients with metastatic NSCLC with EGFR exon 19 deletions or exon 21 mutations.
  • Trabectedin (Yondelis)—Findings from the phase III SAR-3007 trial comparing trabectedin with dacarbazine in patients with advanced liposarcoma or leiomyosarcoma will be presented (Abstract 10503). The FDA is evaluating trabectedin in this clinical setting under its priority review program, according to Janssen, which is developing the drug in the United States.


ASCO abstracts are available at https://iplanner.asco.org/am2015/AM2015.aspx. For breaking news and updates, visit www.OncLive.com.


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