El 11 de septiembre en ESMO se presentara una cohorte B en la que se administra un régimen de dosis nuevo en comparación con la cohorte A que se presentó en el congreso anual de ASCO en 2015.
La PFS en el primer cohorte fue de 4,6 meses y en el segundo cohorte ha sido de 5,3 meses ... y la ORR del 37 % .
Respuestas que son de las más altas que se han conseguido en los ensayos realizados con diversos Farmacos para el Tratamiento de Relapsed Small Cell Lung Cancer a fecha de hoy .
El Perfil de Seguridad en la cohorte B en términos de efectos adversos como neutropenia febril, trombocitopenia y anemia mejoró considerablemente en comparación con la cohorte A.
Dr. Arturo Soto, Director of the Clinical Department at PharmaMar Oncology Business Unit, added “Small Cell Lung Cancer is a devastating disease and the only approved drug for advanced disease is Topotecan. As far as we know these results with lurbinectedin offer the longest PFS seen in this setting and we hope to be able to offer these patients a new treatment option, if we confirm this data in the pivotal clinical trial.”
PharmaMar will present new clinical data on PM1183 during ESMO 2017 ( 11 September 2017 ) :
1529PD // Background
Lurbinectedin (PM01183, L) is a novel anticancer drug that inhibits activated transcription, induces DNA double-strand breaks generating apoptosis, and modulates tumor microenvironment. Relapsed SCLC still remains an unmet medical need.
Methods :
Antitumor activity and safety of Lurbinectedin in SCLC was reviewed in three clinical trials (n = 83 patients): two phase I in combination with doxorubicin (L+DOX; n = 48, two cohorts) or paclitaxel (L+TAX, n = 7), and a phase II single-agent basket trial (n = 28).
Results :
Median age was similar in these three studies. CNS was involved in 33% (L+DOX cohort A), 4% (L+DOX cohort B), 29% (L+TAX) and 0% of patients (L alone). Patients with sensitive disease were 52%, 64%, 71% and 71%, respectively. Activity was seen in the three studies (see Table). The most reported toxicity was hematological (G3-4 neutropenia/thrombocytopenia/febrile neutropenia: L+DOX Cohort A 96%/34%/34%; L+DOX Cohort B 89%/11%/14%; L+TAX 86%/0%/14%, and L alone 32%/4%/4%). Non-hematological toxicity was mainly G1-2 and included fatigue, nausea/vomiting, and transaminase increase.
Conclusions ;
Lurbinectedin shows activity as a single agent and in combination with other agents (DOX and TAX) in relapsed SCLC. Results were remarkable in terms of PFS, DCR and duration of response, especially in platinum-sensitive SCLC. Toxicity mainly consisted of transient myelosuppression, which was manageable with dose reductions and G-CSF use. A randomized Phase III with L+DOX is ongoing (ATLANTIS Study).r .
Table:
| Response Evaluable patients | Lurbinectedin+DOX (q3wk) | Lurbinectedin + TAX (q3wk) | Lurbinectedin alone (q3wk) | |
|---|---|---|---|---|
| Cohort A L 3-5 mg FD D1 + DOX 50 mg/m2 D1 (n = 21) | Cohort B L 2 mg/m2 D1 + DOX 40 mg/m2 D1 (n = 27) | L 2.2 mg/m2 D1 + TAX 80 mg/m2 D1 & D8 (n = 7) | L 3.2 mg/m2 D1 (n = 24) | |
| 2 (10%) | 1 (4%) | 1 (14%) | – | |
| 12(57%) | 9 (33%) | 4 (57%) | 6 (25%) | |
| 3 (14%) | 9 (33%) | – | 12 (50%) | |
| 4 (19%) | 8 (30%) | 2 (29%) | 6 (25%) | |
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Pivotal Phase III On Course :
Pivotal Phase III On Course :
