FDA approved mAbs for solid tumor indications
| Antibody (mAb) | Format | Indication | Target | Year approved | Trial | Trial arm | Comparator | Notes |
|---|---|---|---|---|---|---|---|---|
| Trastuzumab (Herceptin) | Humanized IgG1 mAb | Breast cancer | HER2 | 1998 | mAb + chemotherapy vs. chemotherapy | MTP: 7.2 months ORR: 45% DOR: 8.3 months 1-year survival: 79% | MTP: 4.5 months ORR: 29% DOR: 5.8 months 1-year survival: 68% | Approved in combination with paclitaxel for patients without prior chemotherapy or as a single agent in patients who have progressed on chemotherapy |
| Cetuximab (Erbitux) | Chimeric IgG1 mAb | Colorectal cancer | EGFR | 2004 | mAb + irinotecan vs. mAb | ORR: 22.9% MTP: 4.1 months | ORR: 10.8% MTP: 1.5 months | Assessed in patients who progressed on irinotecan. Approved in combination with irinotecan for patient’s refractory to irinotecan or as a single agent for patients intolerant to irinotecan |
| Bevacizumab (Avastin) | Humanized IgG1 | Colorectal cancer | VEGF | 2004 | mAb + IFL vs. IFL + placebo | MTP: 20.3 months PFS: 10.6 months ORR: 45% DOR: 10.4 months | MTP: 15.6 months PFS: 6.4 months ORR: 35% DOR: 7.1 months | Tested in combination with 5-fluorouracil, irinotecan, leucovorin |
| Panitumumab (Vectibix) | Humanized IgG2 mAb | Colorectal cancer | EGFR | 2006 | mAb + best supportive care vs. best supportive care | PFS: 96 days ORR: 8% | PFS: 60 days ORR: 0% | Assessed in patients who progressed on fluoropyrimidine, oxaliplatin, and irinotecan. No difference in overall survival observed |
| Pertuzumab (Perjeta) | Humanized IgG1 | Breast cancer | HER2 | 2012 | mAb + trastuzumb + docetaxel vs. placebo + trastuzumab + docetaxel | PFS: 18.5 months ORR: 80.2% DOR: 20.2 months Survival: 82.8% | PFS: 12.4 months ORR: 69.3% DOR: 12.5 months Survival: 76.4% | Approved in combination with trastuzumab and docetaxel for patients who have not received prior therapy |
| Ado-trastuzumab emtansine (Kadcyla) | Humanized IgG1 ADC | Breast cancer | HER2 | 2012 | ADC vs. lapatinib + capecitabine | PFS: 9.6 months ORR: 43.6% DOR: 12.6 months MS: 30.9 months | PFS: 6.4 months ORR: 30.8% DOR: 6.5 months MS: 25.1 months | Tested in patients with metastatic or locally advanced breast cancer with prior trastuzumab or prior taxane therapy |
| Ramucirumab (Cyramza) | Human IgG1 | Gastric cancer | VEGFR2 | 2014 | mAb + best supportive care vs. best supportive care + placebo | PFS: 2.1 months MS: 5.2 months | PFS: 1.3 months MS: 3.8 months | Tested in patients with locally advanced or metastatic gastric cancer who previously received platinum or fluoropyrimidine chemo |
| Nivolumab (Opdivo) | Human IgG4 | Melanoma/NSCLC | PD1 | 2014 | Single-arm trial | ORR: 32% | N/A | Tested in patients with unresectable or metastatic melanoma that progressed on ipilimumab |
| Pembrolizumab (Keytruda) | Humanized IgG4 | Melanoma | PD1 | 2014 | Single-arm trial | ORR: 24% | N/A | Tested in patients with unresectable or metastatic melanoma that progressed on ipilimumab |
| Necitumumab (Portrazza) | Human IgG1 | NSCLC | EGFR | 2015 | mAb + gemcitabine + cisplatin vs. gemcitabine + cisplatin | PFS: 5.7 months OS: 23%ORR: 31% MS: 11.5 months | PFS: 5.5 months OS: 19%ORR: 29% MS: 9.9 months | Tested as a first line chemotherapy in patients with metastatic squamous NSCLC |
| Dinutuximab (Unituxin) | Chimeric IgG1 | Neuroblastoma | GD2 | 2015 | mAb + RA vs. RA | OS: 73% EFS: 71% | OS: 58% EFS: 56% | Tested in pediatric patients with high risk neuroblastoma. “RA = 13-cis-retinoic acid” |
| Olaratumab (Lartruvo) | Human IgG1 | Soft tissue sarcoma | PDGFR-alpha | 2016 | mAb + doxorubicin vs. doxorubicin | OS: 41% MS: 26.5 months PFS: 8.2 months ORR: 18.2% | OS: 22% MS: 14.7 months PFS: 4.4 months ORR: 7.5% | Eligible patients were required to have soft tissue sarcoma not amenable to curative treatment with surgery or radiotherapy, a histologic type of sarcoma for which an anthracycline-containing regimen was appropriate but had not been administered |
| Atezolizumab (Tecentriq) | Humanized IgG1 | Bladder cancer | PD-L1 | 2016 | Single-arm trial | ORR: 14.8% | N/A | Tested in patients with locally advanced or metastatic urothelial carcinoma that progressed on platinum containing chemotherapy. |
| Avelumab (Bavencio) | Human IgG1 | Merkel cell carcinoma | PD-L1 | 2017 | Single-arm trial | ORR: 33% | N/A | Tested in patients who progressed on chemotherapy for distant metastatic disease |
| Durvalumab (IMFINZI) | Human IgG1 | Bladder cancer | PD-L1 | 2017 | Single-arm trial | ORR: 17% | N/A | Tested in patients with metastatic urothelial cancer that progressed on or after a platinum-based therapy |
| Cemiplimab (Libtayo) | Human mAb | Cutaneous squamous cell carcinoma | PD-1 | 2018 | Single-arm trial | ORR: 47.2% | N/A | Tested in patients with metastatic or locally advanced CSCC that were not candidates for curative surgery or radiation |
| Enfortumab vedotin (Padcev) | Human IgG1 ADC | Urothelial cancer | Nectin-4 | 2019 | Single-arm trial | ORR: 44% DOR: 7.6 months | N/A | Tested in patients with locally advanced or metastatic urothelial cancer with prior PD-1 or platinum-based chemo |
| [fam-]trastuzumab deruxtecan-nxki (Enhertu) | Humanized IgG1 ADC | Metastatic breast cancer | HER2 | 2019 | Single-arm trial | ORR: 60.3% DOR: 14.8 M | N/A | Tested in patients with HER2-positive, unresectable and/or metastatic breast cancer who had received 2 or more prior anti-HER2 therapies |
| Sacituzumab govitecan-hziy (Trodelvy) | Humanized IgG1 ADC | Triple-neg. breast cancer | TROP-2 | 2020 | Single-arm trial | ORR: 33.3% DOR: 7.7 M | N/A | Tested in patients with metastatic triple negative breast cancer who progressed on 2 prior treatments. |
mAb, antibody; ADC, antibody drug conjugate; OS, overall survival; PFS, progression-free survival; ORR, objective response rate; MS, median survival; DOR, median duration of response; EFS, event-free survival.