| pathology | Demonstrated benefit and harm | k | | | |
|---|
| lung cancer (metastatic) | versus No demonstrated result for efficacy | 3 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Reck, 2016 | ipilimumab + chemotherapy vs placebo + chemotherapy | | | | | Govindan, 2017 | ipilimumab + chemotherapy vs placebo + chemotherapy | | | OS 0.91 [0.77; 1.07] median 13.4 mo vs. 12.4 mo | | phase 2 (phased ipilimumab), 2012 | ipilimumab + chemotherapy vs placebo + chemotherapy | | | |
| Trial | Treatments | Patients | Method |
|---|
| Reck, 2016 | ipilimumab 10 mg/kg plus etoposide and platinum (cisplatin or carboplatin) (n=478) vs. placebo plus etoposide and platinum (cisplatin or carboplatin) (n=476) | patients with newly diagnosed extensive-stage disease SCLC | double-blind Parallel groups Sample size: 478/476 Primary endpoint: FU duration: | | Govindan, 2017 | ipilimumab 10 mg/kg + paclitaxel and carboplatin (n=388) vs. placebo + paclitaxel and carboplatin (n=361) | Patients with stage IV or recurrent chemotherapy-naïve squamous NSCLC | double-blind Parallel groups Sample size: 388/361 Primary endpoint: OS FU duration: | | phase 2 (phased ipilimumab), 2012 | concurrent ipilimumab (four doses of ipilimumab plus paclitaxel and carboplatin followed by two doses of placebo plus paclitaxel and carboplatin) or phased ipilimumab (two doses of placebo plus paclitaxel and carboplatin followed by four doses of ipilimum (n=204) vs. paclitaxel (175 mg/m(2)) and carboplatin (area under the curve, 6) (n=0) | Patients with chemotherapy-naive non-small-cell lung cancer | double-blind Parallel groups Sample size: 204/0 Primary endpoint: immune-related progression-free survival FU duration: |
|
| melanoma | versus chemotherapy ipilimumab + dacarbazine superior to dacarbazine in terms of OS in Robert, 2011 (1L patients) | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Robert, 2011 | ipilimumab + dacarbazine vs dacarbazine | OS 0.72 [0.59; 0.87] median 11.2 mo vs. 9.1 mo Demonstrated | | |
| Trial | Treatments | Patients | Method |
|---|
| Robert, 2011 | ipilimumab (10 mg per kilogram) plus dacarbazine (850 mg per square meter of body-surface area) (n=-9) vs. dacarbazine (850 mg per square meter) (n=-9) | patients with previously untreated metastatic melanoma (stage III (unresectable) orstage IV) | double blind Parallel groups Sample size: -9/-9 Primary endpoint: OS FU duration: |
|
| melanoma | versus gp100 No demonstrated result for efficacy | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Hodi (ipi alone), 2010 | ipilimumab 3 mg/kg vs gp100 | OS 0.64 [0.49; 0.84] median 10.1 mo vs. 6.4 mo | | vitiligo all grade -9.00 [NaN; NaN] vitiligo (grade 3-4) -9.00 [NaN; NaN] | | Hodi (ipi + gp100), 2010 | ipi + gp100 vs gp100 | OS 0.69 [0.56; 0.85] median 10.0 mo vs. 6.4 mo | | vitiligo all grade -9.00 [NaN; NaN] vitiligo (grade 3-4) -9.00 [NaN; NaN] |
| Trial | Treatments | Patients | Method |
|---|
| Hodi (ipi alone), 2010 | ipilimumab 3mg/kg every 3 weeks up to 4 treatments (n=137) vs. gp100 alone (n=136) 3 arms: ipilimumab plus gp100, ipilimumab alone, or gp100 alone | patients with previously treated metastatic melanoma patients with unresectable stage III or IV melanoma, whose disease had progressed while they were receiving therapy for metastatic disease | open-label Parallel groups Sample size: 137/136 Primary endpoint: overall surviva FU duration: | | Hodi (ipi + gp100), 2010 | Ipilimumab, at a dose of 3 mg per kilogram of body weight, was administered with gp100 every 3 weeks for up to four treatments (n=403) vs. gp100 alone
(n=136) 3 arms: ipilimumab plus gp100, ipilimumab alone, or gp100 alone | patients with previously treated metastatic melanoma patients with unresectable stage III or IV melanoma, whose disease had progressed while they were receiving therapy for metastatic disease
| open-label Parallel groups Sample size: 403/136 Primary endpoint: overall surviva FU duration:
|
|
| melanoma | versus placebo or control ipilimumab superior to placebo in terms of recurrence free survival in EORTC 18071 (Eggermont), 2015 (adjuvant patients) ipilimumab inferior to placebo in terms of grade 3-4 in EORTC 18071 (Eggermont), 2015 (adjuvant patients) | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| EORTC 18071 (Eggermont), 2015 | ipilimumab vs placebo | recurrence free survival 0.76 [0.64; 0.90] Demonstrated OS 0.72 [0.58; 0.89] PFS 0.76 [0.64; 0.90] distant metastasis free survival 0.76 [0.63; 0.91] | grade 3-4 2.07 [1.74; 2.46] | |
| Trial | Treatments | Patients | Method |
|---|
| EORTC 18071 (Eggermont), 2015 | ipilimumab at a dose of 10 mg per kilogram every 3 weeks for four doses, then every 3 months for up to 3 years or until disease recurrence or an unacceptable level of toxic effects occurred (n=475) vs. placebo (n=476) | high risk patients who had undergone complete resection of stage III melanoma | double-blind Parallel groups Sample size: 475/476 Primary endpoint: RFS FU duration: 5.3 years phase 3 |
|
