publication date: Oct. 1, 2014
20141001 - Oct. 1, 2014
September 2014PDF

Breast Cancer 
Results from CLEOPATRA Phase III Trial Show Perjeta Increased OS 15.7 Months

Final phase III trial results showed that adding Perjeta to Herceptin and docetaxel chemotherapy increased overall survival to over four-and-a-half years in patients with previously untreated HER2-positive metastatic breast cancer.

Data from the CLEOPATRA study showed that the addition of Perjeta (pertuzumab) increased median overall survival 15.7 months compared to Herceptin (trastuzumab) and docetaxel alone—to 56.5 and 40.8 months, respectively. 

The data were presented at the Presidential Symposium at the European Society for Medical Oncology Congress in Madrid. 

Pancreatic Neuroendocrine Tumors

Afinitor Increases Overall Survival To 3.5 Years in Phase III Trial

An analysis of mature overall survival data from a phase III trial showed that Afinitor increased median overall survival by 6.34 months compared to placebo, for a total of over 3.5 years in patients with well-differentiated advanced and progressive pancreatic neuroendocrine tumors.

Overall survival was a secondary endpoint of the trial. The findings were presented at the European Society for Medical Oncology Congress in Madrid. Results from the primary analysis, which focused on progression-free survival, in which Afinitor (everolimus) more than doubled median PFS compared to placebo, were previously published in the New England Journal of Medicine.

Non-Small Cell Lung Cancer

Merck Serono Cancels Tecemotide Program In NSCLC, Including Two Phase III Trials

Merck Serono will discontinue its worldwide clinical development program of MUC1 antigen-specific immunotherapy tecemotide as a monotherapy in stage III non-small cell lung cancer. This includes the phase III START2 and INSPIRE studies.

The decision comes after a planned analysis of EMR 63325-009, a randomized, double-blind, placebo-controlled phase I/II study in Japanese patients with stage III unresectable, locally advanced NSCLC. Patients had received concurrent or sequential chemoradiotherapy with a minimum of two cycles of platinum-based chemotherapy and radiation dose greater than or equal to 50 Gy.

Multiple Myeloma
Phase III Trial: Panobinostat Increases PFS by Four Months
Gastric Cancer
Phase III Cyramza Trial Meets OS Primary Endpoint
Colorectal Cancer
Phase III Xilonix Study Halted Following Unscheduled Analysis
Ovarian Cancer
Cediranib/Olaparib Combination Nearly Doubles PFS in Phase II
Chemotherapy
Fidaxomicin for CDI Therapy More Cost-Effective Than Vancomycin 
NCI CTEP-Approved Trials for the Month of September
FDA News

  • Keytruda granted accelerated approval in metastatic melanoma

  • FDA approves new indication for Xtandi in prostate cancer

  • FDA removes clinical holds for two agents: ipafricept and PEGPH20

  • Soligenix Inc. reaches agreement with FDA on phase III trial design

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