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• W3136132464 abstract "ABTL0812 induces cytotoxic autophagy-mediated cancer cell death. It induces endoplasmic reticular (ER)-stress, and inhibits Akt/mTOR axis by upregulating TRIB3, an endogenous Akt inhibitor. Both actions, ER stress and blockade of Akt/mTOR, converge to induce a sustained and robust autophagy. Preclinical data in non-small cell lung carcinoma (NSCLC) indicated efficacy as a single agent and synergy with chemotherapy. A phase 1 of ABTL0812 in combination with paclitaxel and carboplatin (P/C) confirmed the safety of the triple combination A single-arm phase 2 study was designed where ABTL0812 was administered 1300 mg TID orally with P/C 175 mg/m2/ AUC5 D1 every 3 weeks, for up to 8 cycles, followed by ABTL0812 as a maintenance until disease progression or unacceptable toxicity. The study enrolled patients with non-irradiable IIIb stage or stage IV squamous-NSCLC. Primary endpoint was overall response rate (ORR) by RECIST criteria v.1.1. Secondary endpoints were progression free survival (PFS), duration of response (DOR), safety and tolerability according to CTCAE v4.03 and pharmacokinetics (PK). Target modulation was assessed by two pharmacodynamic (PD) markers: TRIB3 and CHOP (an ER-stress biomarker) in blood. Thirty-seven patients were screened and 22 were evaluable. ORR was 54.5% (95% CI: 32.2-75.6%), median DOR was 4.9 months (95% CI: 1.4-14.5 months) and median PFS was 6.2 months (CI: 4.4-17.6 months). 91.4% of the pts had any type of adverse event (AE), and any type of related-AE appeared in 60% of the pts. Most frequent related hematological AE of the triple combinations were neutropenia (all grades 8.6%, grade≥3 8.6%), anemia (2.9%, 0%) and febrile neutropenia (2.9%, 2.9%). Most frequent related non-hematological AEs were asthenia (22.9%, 0%), diarrhea (22.9%, 0%), nausea (20.0%, 0%), dysgeusia (14.3%, 0%), and decreased appetite (11.4%, 0%). PK analysis at 4 weeks showed that Cmax is 6.4/5.1 mg/mL and t1/2 3.3/1.6 h for (-)/(+) ABTL0812 enantiomers. Increased TRIB3 and CHOP levels were observed up to 4 weeks after starting treatment. The combination of ABTL0812+P/C compares favorably with historical controls. There is a trend to increased efficacy with no increased toxicity and an acceptable safety and tolerability profile. PK and PD profiles indicate sustained target modulation." @default.
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• W3136132464 date "2021-03-01" @default.
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• W3136132464 title "MA01.06 Phase 2 of Pro-Autophagic Drug ABTL0812 in Combination With First-Line Paclitaxel and Carboplatin in IIIb/IV Squamous NSCLC" @default.
• W3136132464 doi "https://doi.org/10.1016/j.jtho.2021.01.202" @default.
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