Hematology & Oncology 2018 at a glance: Recently approved therapies in oncology BY EMILY BRYER, DO; DAVID MINTZER, MD; Dose: 240 mg orally, once daily. Dacomitinib (Vizimpro) AND DAVID HENRY, MD Adverse Events (AEs): Hyperkalemia and increased Class: Second-generation tyrosine kinase inhibitor. risks of seizures, falls, and fractures. Disease: Metastatic non–small cell lung cancer dvances in genomics and technology per- Phase 3 SPARTAN trial (NCT01946204): 40.5-month (NSCLC) with epidermal growth factor receptor petually change and improve therapies in metastasis-free survival rate, compared with 16.2 (EGFR) exon 19 deletion or exon 21 L858R substi- oncology. Enhanced comprehension of cel- months in the placebo group. tution mutation. lular signaling, division, and replication has Dose: 45 mg orally once daily. createdA a platform to selectively restrict neoplastic Cemiplimab (Libtayo) AEs: Dermatotoxicity and diarrhea. growth while preserving the integrity of benign Class: Antibody against programmed cell death ARCHER1050 trial (NCT01774721): Patients who cells. protein-1 (PD-1). received dacomitinib demonstrated an improved This article reviews therapies that were newly Disease: Metastatic cutaneous squamous cell car- overall survival, with a median of 34.1 months, approved in 2018, as well as those previously ap- cinoma (CSCC) or locally advanced CSCC that is compared with 26.8 months with gefitinib. proved whose indications were expanded this past ineligible for curative surgery/radiation. year. The list highlights the most clinically import- Dose: 350 mg intravenous infusion every 3 weeks. Duvelisib (Copiktra) ant approvals, as well as adverse events that are AEs: Pneumonitis, autoimmune myocarditis, hepa- Class: Dual inhibitor of phosphatidylinositol 3-ki- unique or especially severe. titis, and aseptic meningitis. nase delta and gamma. 1423 and 1540 trials (NCT02383212 and Disease: Relapsed or refractory chronic lymphocyt- Apalutamide (Erleada) NCT02760498): 47.2% of patients who received ic leukemia (CLL), small lymphocytic lymphoma, Class: Androgen receptor inhibitor. cemiplimab had complete disappearance of the tu- or relapsed or refractory follicular lymphoma after Disease: Nonmetastatic castration-resistant pros- mor or a decrease in tumor size. at least two prior systemic therapies. 139308a tate cancer. Dose: 25 mg orally twice daily. Expanded indications for previously approved drugs Drug name Previous indication New indication Landmark study Olaparib (Lynparza) • Maintenance recurrent ovarian cancer • First-line maintenance for BRCA-mutated advanced epithelial SOLO-1 • Advanced germline BRCA mutated ovarian cancer ovarian, fallopian tube, or primary peritoneal cancer (NCT01844986) Pembrolizumab • Unresectable or metastatic melanoma • Recurrent locally advanced or metastatic Merkel cell carcinoma KEYNOTE-017 (Keytruda) • Unresectable or metastatic solid tumors that are microsatellite • Hepatocellular carcinoma in patients who received sorafenib (NCT02267603) instability–high or mismatch repair decient • First-line treatment in combination with chemotherapy for KEYNOTE-224 • Metastatic NSCLC with high program death-ligand 1 expression metastatic squamous NSCLC (NCT02702414) IMNG Print Colors Headline for a Bar Graphic • Recurrent or metastatic NSCLC KEYNOTE-407 If a deck headline is needed, use this style. • Classical Hodgkin lymphoma (NCT02775435) • Recurrent or metastatic cervical cancer Label style and size Nivolumab (Opdivo) • Metastatic melanoma • Metastatic small-cell lung cancer with progression after CHECKMATE-032 • Metastatic NSCLC platinum-based therapy and an additional therapy (NCT01928394) Axes number style and size • Renal cell carcinoma Note: Trade Gothic Medium, 8/11 ush left • Hodgkin lymphoma • Recurrent or metastatic head and neck squamous cell carcinoma Source: Trade Gothic Medium, 8/11 ush left • Locally advanced or metastatic urothelial carcinoma • Microsatellite instability–high or mismatch repair decient Style Guide: metastatic colorectal cancer Keep the background white. • Hepatocellular carcinoma Use the IMNG colors. Brentuximab vedotin • Cutaneous anaplastic large cell lymphoma • Previously untreated systemic anaplastic large-cell lymphoma ECHELON-2 Move the entire graph to align the bar labels left at the blue guide bar. (Acetris) combined • CD30-expressing mycosis fungoides or other CD30-expressing peripheral T-cell lymphomas (NCT01777152) (Resizing may need to be done on the graph to t in the space.) with chemotherapy • Classical Hodgkin lymphoma at high risk of relapse or progression after auto-HSCT consolidation If a deeper or shorter template is needed, adjust in Window > Artboards. • Classical Hodgkin lymphoma after failure of auto-HSCT or after (Standard, as shown here, is 28 picas x 20 picas.) failure of at least two prior multiagent therapies To create the dotted lines if they change, use the clear arrow tool, click Dabrafenib (Tanlar) • Metastatic NSCLC with BRAF 600E mutation • Unresectable or metastatic BRAF V600E mutation–positive BRF117019 on the line that needs to be changed, use the eyedropper tool, then combined with anaplastic thyroid cancer (NCT02034110) click on the dotted rule provided on the side of the template. Trametinib (Mekinist) • Melanoma with BRAF V600E or V600K mutations COMBI-AD (NCT01682083) Blinatumomab • Relapsed or refractory Philadelphia chromosome–negative • B-cell precursor acute lymphoblastic leukemia who are in BLAST (Blincyto) B-cell precursor acute lymphoblastic leukemia remission but still have minimal residual disease (NCT01207388) • Relapsed or refractory Philadelphia chromosome–positive B-cell precursor acute lymphoblastic leukemia MDedge News Note: NSCLC = non–small cell lung cancer, HSCT = hematopoietic stem cell transplantation, BRAF = v-raf murine sarcoma viral oncogene homolog B1. Source: Dr. Bryer, Dr. Mintzer, and Dr. Henry MDedge.com/hematology-oncology ■ April 2019 Hematology & Oncology 139308b AEs: Infection, diarrhea or colitis, and pneumonia. 2018 biosimilars Phase 3 DUO trial (NCT02004522): Progression-free survival in the duvelisib arm was 7.3 months lon- Name Biosimilar to: Indication Headline for a Bar Graphic ger than that in the ofatumumab arm. The overall IMNG Print Colors Adalimumab-adaz Adalimumab • Rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, If a deck headline is needed, use this style. response rate for patients receiving duvelisib was (Hyrimoz) ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, plaque psoriasis 78%, compared with 39% for those receiving ofa- Epoetin alfa-epbx Epoetin alfa • Anemia related to chronic kidney disease, zidovudine with HIV infection, Label style and size tumumab. (Retacrit) myelosuppressive chemotherapy • Reduction of allogenic red blood cell transfusions in elective and noncardiac/ Axes number style and size Gilteritinib (Xospata) nonvascular surgery Note: Trade Gothic Medium, 8/11 ush left Class: Inhibits the FLT3 internal tandem dupli- Filgrastim-aa Filgrastim • Decrease incidence of infection in patients receiving myelosuppressive cation (ITD) and FLT3 tyrosine kinase domain (Nivestym) chemotherapy Source: Trade Gothic Medium, 8/11 ush left (TKD). • Reduce the time to neutrophil recovery and duration of fever in patients with acute myeloid leukemia Style Guide: Disease: Relapsed or refractory acute myeloid leu- • Mobilize autologous hematopoietic progenitor cells into the peripheral blood Keep the background white. kemia (AML) with an FLT3 mutation. for collection by leukapheresis Dose: 120 mg orally daily. Use the IMNG colors. Peglgrastim-jmdb Peglgrastim • Decrease the incidence of infection in patients with nonmyeloid malignancies Move the entire graph to align the bar labels left at the blue guide bar. ADMIRAL trial (NCT02421939): 21% of the patients (Fulphila) receiving myelosuppressive anticancer drugs associated with a signicant (Resizing may need to be done on the graph to t in the space.) who received gilteritinib exhibited complete remis- incidence of febrile neutropenia If a deeper or shorter template is needed, adjust in Window > Artboards. sion or complete remission with partial hemato- Peglgrastim-cbqv Peglgrastim • Same indications as peglgrastim-jmdb logic recovery. (Udenyca) (Standard, as shown here, is 28 picas x 20 picas.) Rituximab-abbs Rituximab • CD20-positive B-cell non-Hodgkin lymphoma To create the dotted lines if they change, use the clear arrow tool, click Glasdegib (Daurismo) (Trumixa) on the line that needs to be changed, use the eyedropper tool, then Class: Hedgehog pathway inhibitor. Trastuzumab-pkrb Trastuzumab • HER2-overexpressing breast cancer click on the dotted rule provided on the side of the template. Disease: Adults over age 75 years with newly diag- (Herzuma) nosed AML and other medical comorbidities that MDedge News preclude them from intensive chemotherapy. Source: Dr. Bryer, Dr. Mintzer, and Dr. Henry Dose: The recommended dose is 100 mg orally continuously in 28-day cycles. AE: QT prolongation and embryo-fetal toxicity Larotrectinib (Vitrakvi) Moxetumomab pasudotox-tdfk (Lumoxiti) Phase 2 BRIGHT 1003 trial (NCT01546038): Class: Oral tyrosine kinase inhibitor. Class: CD22-directed cytotoxin fused with a frag- 3.9-month overall survival advantage for glasdegib Disease: Advanced solid tumors harboring a neu- ment of Pseudomonas exotoxin A. plus cytarabine, compared with cytarabine alone. rotrophic tyrosine receptor kinase (NTRK) gene Disease: Relapsed or refractory hairy cell leukemia Overall,