Clinical Intelligence

Eisai initiates two phase III trials with FYCOMPA (Perampanel) for epilepsy

Wednesday, November 2, 2016

Eisai has announced the initiation of two multicenter, global phase III clinical trials assessing FYCOMPA (perampanel) CIII in two different patient populations: patients age 2 years and above with inadequately controlled seizures associated with Lennox-Gastaut Syndrome (LGS) (Study 338), a rare and often debilitating form of childhood-onset epilepsy, and in children ages 4 through 11 years with inadequately controlled partial-onset seizures (POS) (Study 311).

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ReViral initiates phase I trial for respiratory syncytial virus

Tuesday, November 1, 2016

ReViral, an antiviral drug discovery and development company developing innovative therapies against Respiratory Syncytial Virus (RSV), has initiated a phase I clinical trial for RV521, its novel orally-active small molecule inhibitor of RSV fusion. RSV infection is an area of significant unmet medical need and RV521 is being developed to treat RSV in patients with severe disease including neonates, the elderly, the immunocompromised and those with underlying cardiovascular or respiratory disease.

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Agilent Technologies receives expanded FDA approval to inform treatment in non-small cell lung cancer (NSCLC)

Thursday, October 27, 2016

Agilent Technologies Inc. announced that its Dako PD-L1 IHC 22C3 pharmDx now has an expanded label approved by the U.S. Food and Drug Administration (FDA) for use in determining PD-L1 expression status to inform treatment in metastatic non-small cell lung cancer (NSCLC) with KEYTRUDA® (pembrolizumab). This expanded intended use now allows the PD-L1 IHC 22C3 pharmDx test to detect PD-L1 expression in a broader range of patients–those with a PD-L1 tumor proportion score (TPS) of 1 percent or more.

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Merck’s Keytruda study meets primary endpoint and stops early

Monday, October 24, 2016

Merck, known as MSD outside the U.S. and Canada, has announced that the phase III KEYNOTE-045 trial investigating the use of KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy, in patients with previously treated advanced urothelial cancer, met the primary endpoint of overall survival (OS). In this trial, KEYTRUDA was superior compared to investigator choice chemotherapy. Based on a pre-specified interim analysis, an independent Data Monitoring Committee (DMC) has recommended that the trial be stopped early.

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Advaxis initiates combination portion of phase I/II study with Merck & Co.

Monday, October 24, 2016

Advaxis, clinical stage biotechnology company developing cancer immunotherapies, has announced the commencement of Part B of the KEYNOTE-046 clinical trial evaluating Advaxis’ Lm immunotherapy candidate, ADXS-PSA, in combination with KEYTRUDA (pembrolizumab) in patients with previously treated, metastatic castration-resistant prostate cancer (mCRPC). In Part A of the phase I/II study, 14 patients were treated with ADXS-PSA monotherapy across three dose levels, with no dose limiting toxicities, paving the way for initiating Part B of the study.

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FDA approves Eli Lilly’s LARTRUVO (Olaratumab)

Monday, October 24, 2016

The FDA has granted approval of Eli Lilly’s LARTRUVO (olaratumab injection, 10 mg/mL), in combination with doxorubicin, for the treatment of adults with soft tissue sarcoma (STS) with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery. LARTRUVO’s indication is approved under Accelerated Approval, and is based on data from the phase II portion of the pivotal JGDG trial. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. LARTRUVO, in combination with doxorubicin, is the first FDA-approved front-line therapy for STS in four decades. The confirmatory phase III trial, ANNOUNCE, is fully enrolled.

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