SCLC .This approval for Opdivo in patients with SCLC whose cancer has progressed after two or more prior lines of therapy was granted priority review from the FDA.

Con Opdivo Doce pacientes tuvieron una respuesta parcial ( PR ) que representa un 11% y un paciente tuvo una respuesta completa ( CR ) (0,9 %) .

Aquí los resultados que de momento se conocen con Zepsyre :

Janssen Scientific Affairs, LLC ( Collaborator ) y la Universidad de Miami Marilyn Huang ( Sponsor ) iniciaran en Octubre el Ensayo Clinico con la Triple Combinación de Yondelis + Olaratumab ( Lartruvo de Lilly ) + Doxorubicin para Leiomyosarcoma .

Olaratumab ( Comercializado con el Nombre de Lartruvo por Lilly )  es un Anticuerpo Monoclonal que ya ha demostrando que combinado con Doxorubin obtienen una Supervivencia Global  de 12 meses respecto al tratamiento con Doxorubicin solo ... Ahora con esta doble combinación se llevara a cabo un nuevo ensayo clinico añadiendole el Yondelis .

  Este estudio buscara determinar si la adición de Yondelis (Trabectedina (T) a la Combinación de Doxorrubicina (D) y Olaratumab (O) es factible y tolerable con actividad antitumoral en pacientes con leiomiosarcomas metastásicos o recurrentes (LMS) que tienen opciones terapéuticas limitadas.

This is a traditional 3+3 phase I trial design to identify the recommended phase II dose (RP2D) of Trabectedin [T] that can be used in combination with Doxorubicin [D] and Olaratumab [O] for the treatment of patients with advanced stage or recurrent LMS.

Patients will be treated at an assigned dose level of combination therapy per dose escalation design. The initial dose level (1) to be tested is as follows: Olaratumab 15mg/kg followed by Doxorubicin 75mg/m2 then Trabectedin 0.5mg/m2 on day 1 over 24 hours. Granulocyte-colony stimulating factor (G-CSF) support will be administered on day 3. Olaratumab will be also given on day 8. Planned treatment is every 21-days for 8 cycles of combination Trabectedin, Doxorubicin and Olaratumab (TDO).

FDA Grants Accelerated Approval to Nivolumab for Small Cell Lung Cancer .

The US Food and Drug Administration (FDA) has approved nivolumab for the treatment of patients with metastatic small cell lung cancer (SCLC) who have failed platinum-based chemotherapy and at least 1 other line of therapy, according to a press release.1

This marks the first time a drug has been approved for this indication in nearly 2 decades, and also makes nivolumab the first and only available immuno-oncology agent for this patient population.

The FDA based its decision on results from a cohort of the ongoing CheckMate-032 (ClinicalTrials.gov identifier: NCT01928394) phase 1/2 study, in which researchers are investigating nivolumab in patients with advanced or metastatic tumors who have failed and experienced disease progression after platinum-based chemotherapy. For this particular cohort, 109 patients with SCLC were treated with nivolumab 3 mg/kg every 2 weeks regardless of PD-L1 status. The first tumor assessment was performed 6 weeks after treatment initiation, then every 6 weeks for 6 months, then every 12 weeks thereafter.

Results showed that 13 (12%; 95% CI, 6.5-19.5) patients had a response to therapy according to a Blinded Independent Central Review; 12 (11%) patients had a partial response and 1 (0.9%) patient had a complete response. The median duration of response was 17.9 months (95% CI, 7.9-42.1) among responsive patients.