Abstract 721P
Background
A compassionate use program of Ipilimumab and nivolumab (IPI-NIVO) was open in Italy from Apr to Oct 2019, enrolling patients (pts) with metastatic renal cell Carcinoma (RCC) with intermediate or poor International Metastatic RCC Database Consortium (IMDC) score.
Methods
Retrospective analysis of safety and activity of IPI-NIVO administered to pts with metastatic RCC and no prior treatment. IPI was infused at 1 mg/Kg plus Nivolumab 3mg/Kg every three weeks for four doses, followed by maintenance Nivolumab (240 or 480 mg flat dose every 2 or 4 weeks, respectively) until progression or unacceptable toxicity.
Results
A total of 324 pts started IPI-NIVO at 86 Italian Centers. Median age was 62 yrs (range 23 to 87 yrs, 75 pts 70-79yrs, 13 ≥80 yrs), 74% males. According to IMDC criteria, 69% were Intermediate and 31% poor risk. Primary tumor had been removed in 64% of pts. Histology was clear cell in 262 pts (81%), papillary in 22 (8%), unclassified in 12 (4%); Sarcomatoid features were present in 14% of pts. Two hundred thirty-six pts (72.8%) completed the four doses of IPI-NIVO. Causes of premature interruption of the combination were disease progression in 44 pts (50%) and toxicity in 44 pts (50%) (Table). At a median follow-up of 9 months, 48.8% of pts are still on treatment.
Conclusions
More than two-thirds of this real-world cohort of metastatic RCC pts completed the induction phase of IPI-NIVO. Updated PFS and OS data will be presented at the meeting. Table: 721P
Toxicity events causing early interruption of IPI-NIVO combination
| Pts | % | |
| Intestinal | 14 | 31.8 |
| Hepatic | 7 | 15.9 |
| Pulmonary | 5 | 11.4 |
| Pancreatic | 5 | 11.4 |
| Neurological | 4 | 9.1 |
| Cardiac | 1 | 2.3 |
| Hyperthyroidism | 1 | 2.3 |
| Allergic reaction | 1 | 2.3 |
| Other | 6 | 13.5 |
| Total | 44 | 100 |
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
U. Basso: Advisory/Consultancy, Travel/Accommodation/Expenses, Speaker's fees: Janssen-Cilag; Advisory/Consultancy: MSD; Advisory/Consultancy, Travel/Accommodation/Expenses, Speaker's fees: Bristol Myer Squibb; Advisory/Consultancy: Incyte; Research grant/Funding (self): Apsen; Travel/Accommodation/Expenses, Speaker's fees: Astellas; Travel/Accommodation/Expenses, Speaker's fees: Novartis; Advisory/Consultancy, Travel/Accommodation/Expenses, Speaker's fees: Sanofi; Travel/Accommodation/Expenses, Speaker's fees: Pfizer. C.G. Porta: Honoraria (institution), Speaker Bureau/Expert testimony: MSD; Honoraria (self): BMS; Honoraria (institution), Speaker Bureau/Expert testimony: AstraZeneca; Speaker Bureau/Expert testimony: Pfizer ; Honoraria (self), Speaker Bureau/Expert testimony: Ipsen; Honoraria (self), Speaker Bureau/Expert testimony: Eusa; Honoraria (self), Speaker Bureau/Expert testimony: Eisai; Honoraria (self): Merck; Travel/Accommodation/Expenses: Roche; Speaker Bureau/Expert testimony: Novartis; Speaker Bureau/Expert testimony: Janssen. U. De Giorgi: Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): Roche; Advisory/Consultancy, Research grant/Funding (self): Sanofi Aventis; Advisory/Consultancy: Astellas; Advisory/Consultancy, Travel/Accommodation/Expenses: Janssen; Advisory/Consultancy: Bayer; Advisory/Consultancy, Travel/Accommodation/Expenses: BMS; Advisory/Consultancy: Merck; Travel/Accommodation/Expenses: Ipsen; Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer. G. Fornarini: Advisory/Consultancy: Pfizer; Advisory/Consultancy: MSD; Advisory/Consultancy: Astellas; Advisory/Consultancy: Merck; Advisory/Consultancy: Sanofi; Advisory/Consultancy: Roche; Advisory/Consultancy: Janssen. P.A. Zucali: Advisory/Consultancy: BMS; Advisory/Consultancy: Sanofi Aventis; Advisory/Consultancy: Pfizer ; Advisory/Consultancy: msd; Advisory/Consultancy: Astellas; Advisory/Consultancy: Janssen; Advisory/Consultancy: Ipsen; Advisory/Consultancy: Novartis. C. Baldessari: Travel/Accommodation/Expenses: Astellas; Travel/Accommodation/Expenses: Pierre Fabre. V. Zagonel: Advisory/Consultancy, Speaker Bureau/Expert testimony: BMS; Advisory/Consultancy: Celgene; Advisory/Consultancy, Travel/Accommodation/Expenses: Merck; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Bayer; Speaker Bureau/Expert testimony: Janssen; Speaker Bureau/Expert testimony: Pfizer; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Roche; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Servier; Speaker Bureau/Expert testimony: Lilly; Speaker Bureau/Expert testimony: AstraZeneca. All other authors have declared no conflicts of interest.