ZEPZELCA ( Lurbinectedin de PharmaMar ) Combinado con CAMPTOSAR ( Irinotecan de Pfizer ) . Presentación Oral en el IASLC 2020 World Conference on Lung Cancer, Which Will Be Held Virtually From January 31st .

Titulo de la Presentación Oral :

Lurbinectedin With Irinotecan in Relapsed Small Cell Lung Cancer. Results From the Expansion Stage of a Phase I-II Trial .

In The Oral Presentation, New Data on The Lurbinectedin Combination With Irinotecan in Relapsed Small Cell Lung Cancer (SCLC) Will Be Presented, Under The Abstract 'Lurbinectedin With Irinotecan In Relapsed Small Cell Lung Cancer. Results From The Expansion Stage Of a Phase I-II Trial'.

This Combination Of Lurbinectedin And Irinotecan Demonstrated Efficacy in SCLC After Failure Of First-Line therapy, including 'remarkable activity in patients with resistant disease (CTFI .

Al Ser una Presentación Oral ... De Momento Tan Solo Tenemos los Resultados  Obtenidos a Fecha de  12 Agosto 2020 ...  Que Ya Anticipan Muy Muy Muy Buenos Resultados Con Un Beneficio Clinico del 71 %  ... Logicamente Estos Resultados Pueden Tener Variaciones en la Presentación Oral de Este Domingo .

Resultados con Fecha 12 Agosto 2020 : 

Lurbinectedin is a Novel anti-cancer agent that exerts antitumor activity through inhibition of trans-activated transcription and modulation of the tumor microenvironment.

 In June 2020, the US FDA granted accelerated approval to lurbinectedin (ZepzelcaTM) for the treatment of adult patients (pts) with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy based on the results of a phase II study (Trigo et al. Lancet Oncol 2020). Preclinical evidence of synergism was observed for lurbinectedin in combination with irinotecan.

Methods

Antitumor activity and the safety of lurbinectedin in combination with irinotecan in SCLC were evaluated in this phase I-II trial. Data are presented here for advanced SCLC (pts) with no more than 2 prior lines of chemotherapy and ECOG performance status (PS) score of 0-1 treated at the recommended dose (RD).

Results

21 pts were treated at the RD (lurbinectedin 2 mg/m2 Day 1 + irinotecan 75 mg/m2 Days 1 and 8 every three weeks + prophylactic G-CSF); all were evaluable for safety and efficacy. Baseline characteristics were: males/females, 48%/52%; median age, 61 years (52-74); ECOG PS score 0/1, 24%/76%; chemotherapy-free interval (CTFI) ≥90 days/<90 days, 62%/38%; number of prior lines, 1 (62%), 2 (38%); prior immunotherapy (19%); liver metastases 48%; CNS involvement 24%. At cut-off (12 August 2020), 11 patients were still on treatment.

 Adverse events (AEs) included:

Grade (G) 4 neutropenia in 6 pts (28.6%); febrile neutropenia in 2 pts (9.5%); no G4 anemia or G4 thrombocytopenia. Severe non-hematological toxicities were G3 only and consisted mainly of fatigue in 4 pts (19.0%), diarrhea in 3 pts (14.3%), and vomiting in 1 pt (4.5%). No deaths or discontinuations were reported due to treatment-related AEs.

Conclusion

The combination of lurbinectedin and irinotecan demonstrated efficacy in SCLC after failure of first-line therapy, including remarkable activity in pts with resistant disease (CTFI <90 days) and in the 3rd line setting. Toxicity was transient and manageable, and consisted mainly of hematological abnormalities, fatigue and diarrhea. Further development of this combination is warranted in pts with SCLC. Updated results of this cohort will be presented.

All patients (n=21)	CTFI		Setting
	≥90 days (n=13)	<90 days (n=8)	2nd line (n=13)	3rd line (n=8)
Median number of cycles (range)	7 (1-16)	9 (3-16)	3 (1-7)	7 (3-16)	7 (1-13)
Overall Response Rate (PR)	62%	69%	50%	77%	37%
Clinical Benefit Rate (PR+SD>4m)	71%	85%	50%	77%	63%
Disease Control Rate (PR+SD)	90%	100%	75%	100%	75%
Median DOR (m) (95% CI)	5.7+ (2.8-n.r.)	6.7+ (3.0-n.r.)	3.2+ (2.8-3.7)	6.7+ (3.0-n.r.)	3.0+ (2.8-n.r.)
Median PFS (m) (95% CI)	6.2+ (4.1-n.r.)	8.5+ (4.3-n.r.)	3.7+ (0.7-5.0)	8.1+ (3.3-n.r.)	4.3+ (0.7-n.r.)
Median follow-up: 8.7 months + patients ongoing; CTFI, chemotherapy-free interval; DOR, duration of response; m, months; n.r. not reached; PFS, progression-free survival; PR, partial response; SD, stable disease.