Table 3.

Phase 2 clinical efficacy of Tigatuzumab (TIG) in combination with gemcitabine, sorafenib, and nab-PAC/Abraxane.

Trial Phase	Combination Agents	Type of Cancer	Progression-Free Survival (PFS)	Overall Survival (OS)	Conclusions
Phase II	Tigatuzumab + Gemcitabine	Unresectable or metastatic pancreatic cancer	52.5% PFS at 16 weeks; not significant from historical data at 44% seen with gemcitabine alone [57]	8.2 months; comparable to 3.6–6.8 months (gemcitabine alone), 3.8–11.1 months (gemcitabine + other agents), 11.1 months (FOLFIRINOX trial) [57]	Marginal increase in overall survival with TIG compared to gemcitabine alone suggests possible contribution of TIG to anti-tumor effects of gemcitabine; TIG may be clinically active [57]
Phase II	Tigatuzumab + Sorafenib	Advanced hepatocellular carcinoma	Time to progression (TTP): 3.9 months in 6/6 mg/kg TIG + SOR; 2.8 months in SOR alone (small sample size p = 0.988) [54]	12.2 months in TIG + SOR; 8.2 months in SOR alone (small sample size p = 0.737) [54]	TIG + SOR failed to meet primary efficacy endpoint of TTP. However, combination was well tolerated and suggests possible increase in OS for TIG [54]
Phase II	Tigatuzumab + nab-PAC/Abraxane	Metastatic triple-negative breast cancer (TNBC)	2.8 months overall in TIG + nab-PAC, 3.8 months in patients with objective response; 3.7 months in nab-PAC arm [58]	Overall response rate (ORR): 28% (CI 14.9–45.0% in TIG + nab-PAC; 38% (CI 18.0–61.1%) in nab-PAC arm [58]	3 complete responses (CR) + 1 near CR in TIG + nab-PAC arm; no CR in nab-PAC arm; does not support further research of TIG + nab-PAC; however, notable increase in complete responses suggests further investigation of anti-DR5 agents [58]