Advanced Soft Tissue Sarcoma Drug Failure in Top Cancer News


Recent advances and updates in oncology and cancer drug development.

Aldoxorubicin Misses PFS Endpoint in Phase III STS Study

Treatment with aldoxorubicin failed to improve progression-free survival compared with investigator's choice of therapy for patients with advanced soft tissue sarcoma. The analysis, which was conducted after 191 progression events, showed a median PFS of 4.17 months with aldoxorubicin compared with 4.04 months with investigator's choice of therapy, which included doxorubicin or pazopanib (HR, 0.91).

Patients treated with aldoxorubicin experienced an improvement in ORR compared with investigator's choice that was described as a “doubling in response,” although the statistical significance of this improvement was not announced. The disease control rate was also improved versus investigator's choice (P = .048). Aldoxorubicin-related adverse events were consistent with prior studies. Full findings were not yet announced for secondary endpoints, with follow up still ongoing for overall survival. Full results are expected at an upcoming meeting, with findings from a second analysis anticipated in the fourth quarter of 2016.

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Adjuvant Sunitinib Improves DFS in RCC

Sunitinib extended disease-free survival versus placebo as an adjuvant therapy for patients with renal cell carcinoma at high risk of recurrence in the phase III S-TRAC trial. The safety profile for sunitinib in the S-TRAC study was consistent with previously reported adverse-event data for the drug. The top level results from this study have caused confusion, as the larger ASSURE trial exploring adjuvant sunitinib was negative.

In the ASSURE study, neither sunitinib nor sorafenib improved outcomes when administered after surgery to patients with locally advanced RCC. There were subtle differences between the two studies, including imaging via central review and the histology of RCC included. The full data from the study will be eagerly anticipated to discover what may have caused the differences between the trials. Pfizer plans to submit the full trial data for presentation at the 2016 ESMO Congress in October.

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FDA Places Clinical Hold on Phase II JCAR015 Trial

The FDA has placed a clinical hold on a phase II study exploring the CD19-targeted CAR-T cell therapy JCAR015 for adult patients with relapsed or refractory B cell acute lymphoblastic leukemia. The hold is meant to address 3 deaths that occurred in the trial from cerebral edema, which might be related to the recent addition of fludarabine to the preconditioning regimen used in the study. Two of the deaths occurred within the past week, leading to the halt.

The first death was seen in May, although the cause of this event could not be determined. In response to the hold, Juno plans to omit fludarabine from the trial, which is known as ROCKET, and will provide a complete response to the FDA this week. As part of the complete response, the FDA requested that Juno submit a revised patient informed consent form, investigator brochure, and trial protocol along with a copy of information presented to the agency. The FDA typically reviews this type of information submission within 30 days.

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FDA Releases Draft Guidelines on NGS

The FDA has issued two draft guidelines that will provide regulatory oversight for the use of next-generation sequencing-based tests. The utilization of the novel technology—which can examine millions of DNA variants at one time—has been expanding as a means to inform risk and treatment decisions across multiple tumor types. Guidance documents represent the FDA’s current thinking on a particular subject.

Draft guidelines are undergoing finalization and the FDA encourages public comments regarding the draft during the 90-day comment period. The guidelines are part of the of the FDA’s engagement in the Precision Medicine Initiative, created by the White House in early 2015. The FDA’s role in the PMI is to create regulatory processes that encourage advances in genomic testing while assuring that NGS-based tests are safe and effective. The agency has been working with experts in the genomics community to conceptualize an approach that strikes a balance between safeguarding public health and promoting innovation.

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EC Expands Brentuximab Vedotin Label for Hodgkin Lymphoma

The European Commission has approved brentuximab vedotin for use as a consolidation therapy following autologous stem cell transplantation in patients with CD30-positive Hodgkin lymphoma at risk of relapse or progression. The approval was based on the phase III AETHERA trial, in which brentuximab vedotin reduced the risk of disease progression by 43% compared with placebo.

The median progression-free survival with brentuximab vedotin was 42.9 months versus 24.1 months with placebo (HR, 0.57; P = .001). Along with the expanded indication, the EC also extended the existing conditional marketing approvals for brentuximab vedotin in Europe. The EC decision, which follows a recent positive opinion issued by the EMA’s Committee for Medicinal Products for Human Use, means that brentuximab vedotin is now approved for these indications in the European Union, Norway, Liechtenstein, and Iceland.

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