The INCA trial, a phase II study investigating the anti-CD22 immunoconjugate drug Inotuzumab Ozogamicin (IO) and the combined chemotherapy drug R-CVP (rituximab, cyclophosphamide, vincristine and prednisolone) in patients with newly diagnosed diffuse large B-cell lymphoma, closed to recruitment at the end of March 2019.
INCA opened in October 2013. It was the second trial run by UCL CTC to investigate ways to improve treatment for patients with diffuse large B-cell who are not fit to receive standard R-CHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone) because they are at a high risk of cardiac complications from doxorubicin.
Its predecessor was R-GCVP, in which gemcitabine was added to rituximab, cyclophosphamide, vincristine and prednisolone. 62 patients were treated with the R-GCVP combination between 2008-2010, and with over 60% of patients entering complete remission and nearly 50% surviving at least 2 years without progression of their lymphoma, the results were promising enough that Gemcitabine-RCVP (Gem-RCVP) became the standard arm of the INCA trial.
128 patients were recruited to the INCA trial between October 2013 and March 2019. They were randomised to be treated with either IO-RCVP or Gem-RCVP. The study looks at whether the number of disease progressions and deaths in patients treated with IO-RCVP is lower than in patients treated with Gem-RCVP. The trial team are also looking at how well people’s disease responds, what side effects patients experience, and how treatment impacts their quality of life.
Scientists at the Haematological Malignancy Diagnostic Service in Leeds are carrying out tests on tumour samples from patients on the INCA trial to help understand more about diffuse large B-cell lymphoma and how the genetics of lymphoma cells influence how well treatment works.
The Chief Investigator of the trial, Dr Andrew McMillan from Nottingham City Hospital, said: ‘We have known for a long time that R-CHOP is the best treatment for DLBCL. However, some patients with previous heart problems are unable to receive it because one of the drugs can affect the heart. The R-GCVP trial addressed this issue with encouraging results, but the new targeted drug Inotuzumab Ozogamicin has the potential to be more effective in this context, so this trial has compared the two approaches to see which might be better’.
The final patients on INCA will finish treatment in summer 2019, and results will be available by the end of the year.
The INCA trial was supported by Pfizer.