April Salama

Positions:

Associate Professor of Medicine

Medicine, Medical Oncology
School of Medicine

Member of the Duke Cancer Institute

Duke Cancer Institute
School of Medicine

Education:

M.D. 2004

University of North Carolina - Chapel Hill

Internal Medicine

The University of Chicago

Hematology/Oncology

The University of Chicago

Grants:

Collaborative Success: Expanding Options for Patients with Melanoma

Administered By
Duke Cancer Institute
Awarded By
National Institutes of Health
Role
Project Lead
Start Date
End Date

A Multicenter, Open label, Phase III Extension Trial to Study the Long-term Safety and Efficacy in Participants with Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab Trial.

Administered By
Duke Cancer Institute
Awarded By
Merck Sharp & Dohme
Role
Principal Investigator
Start Date
End Date

INCB 24360-208 A Phase 1/2, Open-Label, Dose-Escalation, Safety, Tolerability, and Efficacy Study of Epacadostat and Nivolumab in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies (ECHO-208)

Administered By
Duke Cancer Institute
Awarded By
Incyte Corporation
Role
Principal Investigator
Start Date
End Date

A Phase 3, Randomized Study of Adjuvant Immunotherapy with Nivolumab Combined with Ipilimumab versus Nivolumab Monotherapy after Complete Resection of Stage IIIb/c/d or Stage IV Melanoma

Administered By
Duke Cancer Institute
Awarded By
Bristol-Myers Squibb Company
Role
Principal Investigator
Start Date
End Date

A Phase II Randomized, Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 Compared with Investigator's Choice in HLA-A*0201 Positive Patients with Previously Untreated Advanced Uveal Melanoma

Administered By
Duke Cancer Institute
Awarded By
Immunocore Limited
Role
Principal Investigator
Start Date
End Date

Publications:

NCCN Guidelines® Insights: Melanoma: Cutaneous, Version 2.2021.

Over the past few years, the NCCN Guidelines for Melanoma: Cutaneous have been expanded to include pathways for treatment of microscopic satellitosis (added in v2.2020), and the following Principles sections: Molecular Testing (added in v2.2019), Systemic Therapy Considerations (added in v2.2020), and Brain Metastases Management (added in v3.2020). The v1.2021 update included additional modifications of these sections and notable revisions to Principles of: Pathology, Surgical Margins for Wide Excision of Primary Melanoma, Sentinel Lymph Node Biopsy, Completion/Therapeutic Lymph Node Dissection, and Radiation Therapy. These NCCN Guidelines Insights discuss the important changes to pathology and surgery recommendations, as well as additions to systemic therapy options for patients with advanced disease.
Authors
Swetter, SM; Thompson, JA; Albertini, MR; Barker, CA; Baumgartner, J; Boland, G; Chmielowski, B; DiMaio, D; Durham, A; Fields, RC; Fleming, MD; Galan, A; Gastman, B; Grossmann, K; Guild, S; Holder, A; Johnson, D; Joseph, RW; Karakousis, G; Kendra, K; Lange, JR; Lanning, R; Margolin, K; Olszanski, AJ; Ott, PA; Ross, MI; Salama, AK; Sharma, R; Skitzki, J; Sosman, J; Wuthrick, E; McMillian, NR; Engh, AM
MLA Citation
Swetter, Susan M., et al. “NCCN Guidelines® Insights: Melanoma: Cutaneous, Version 2.2021.J Natl Compr Canc Netw, vol. 19, no. 4, Apr. 2021, pp. 364–76. Pubmed, doi:10.6004/jnccn.2021.0018.
URI
https://scholars.duke.edu/individual/pub1478544
PMID
33845460
Source
pubmed
Published In
J Natl Compr Canc Netw
Volume
19
Published Date
Start Page
364
End Page
376
DOI
10.6004/jnccn.2021.0018

Phase I trial of intratumoral PVSRIPO in patients with unresectable, treatment-refractory melanoma.

BACKGROUND: While programmed cell death protein 1 (PD-1) and programmed death-ligand 1 (PD-L1) antagonists have improved the prognosis for many patients with melanoma, around 60% fail therapy. PVSRIPO is a non-neurovirulent rhinovirus:poliovirus chimera that facilitates an antitumor immune response following cell entry via the poliovirus receptor CD155, which is expressed on tumor and antigen-presenting cells. Preclinical studies show that oncolytic virus plus anti-PD-1 therapy leads to a greater antitumor response than either agent alone, warranting clinical investigation. METHODS: An open-label phase I trial of intratumoral PVSRIPO in patients with unresectable melanoma (American Joint Committee on Cancer V.7 stage IIIB, IIIC, or IV) was performed. Eligible patients had disease progression on anti-PD-1 and V-raf murine sarcoma viral oncogene homolog B (BRAF)/mitogen activated protein kinase kinase (MEK) inhibitors (if BRAF mutant). The primary objective was to characterize the safety and tolerability of PVSRIPO. Twelve patients in four cohorts received a total of 1, 2 or 3 injections of PVSRIPO monotherapy, with 21 days between injections. RESULTS: PVSRIPO injections were well tolerated with no serious adverse events (SAEs) or dose-limiting toxicities (DLTs) reported. All adverse events (AEs) were grade (G) 1 or G2 (G1 pruritus most common at 58%); all but two PVSRIPO-treatment related AEs were localized to the injected or adjacent lesions (n=1 G1 hot flash, n=1 G1 fatigue). Four out of 12 patients (33%) achieved an objective response per immune-related response criteria (two observations, 4 weeks apart), including 4/6 (67%) who received three injections. In the four patients with in-transit disease, a pathological complete response (pCR) was observed in two (50%) patients. Following study completion, 11/12 patients (92%) reinitiated immune checkpoint inhibitor-based therapy, and 6/12 patients (50%) remained without progression at a median follow-up time of 18 months. CONCLUSION: Intratumoral PVSRIPO was well tolerated. Despite the limited number of PVSRIPO treatments relative to the overall lesion burden (67% patients>5 lesions), intratumoral PVSRIPO showed promising antitumor activity, with pCR in injected as well as non-injected lesions in select patients. TRIAL REGISTRATION NUMBER: NCT03712358.
Authors
Beasley, GM; Nair, SK; Farrow, NE; Landa, K; Selim, MA; Wiggs, CA; Jung, S-H; Bigner, DD; True Kelly, A; Gromeier, M; Salama, AK
MLA Citation
Beasley, Georgia M., et al. “Phase I trial of intratumoral PVSRIPO in patients with unresectable, treatment-refractory melanoma.J Immunother Cancer, vol. 9, no. 4, Apr. 2021. Pubmed, doi:10.1136/jitc-2020-002203.
URI
https://scholars.duke.edu/individual/pub1480357
PMID
33875611
Source
pubmed
Published In
Journal for Immunotherapy of Cancer
Volume
9
Published Date
DOI
10.1136/jitc-2020-002203

Overall Survival Improved for Contemporary Patients with Melanoma: A 2004-2015 National Cancer Database Analysis.

INTRODUCTION: Since 2011, encouraging clinical trial results have led to approval of multiple new therapies for advanced melanoma, but the impact of these therapies outside of trial populations is largely unknown. This study examines use of novel therapies and survival in contemporary patients with melanoma. METHODS: Stage I-IV melanoma patients were identified in the 2004-2015 National Cancer Database and grouped into historic (2004-2010) and contemporary (2011-2015) cohorts. Overall survival (OS) was compared using Kaplan-Meier and Cox proportional hazard modeling adjusting for patient, tumor, and facility characteristics. RESULTS: Of 268,668 patients, 136,828 were classified as historic and 131,840 as contemporary. Among all stages, immunotherapy utilization was significantly higher among contemporary patients (5.3% vs. 5.1%, p = 0.006). Adjusted OS was improved in the contemporary cohort (hazard ratio [HR]: 0.90 p < 0.001). There was no difference in OS among stage I/II patients between groups (HR: 0.99, p = 0.63), while OS was significantly improved for contemporary stage III/IV patients (HR: 0.85, p < 0.001). Among stage III/IV patients who received immunotherapy, OS was improved for the contemporary cohort (HR: 0.87, p = 0.014). CONCLUSIONS: Adjusted overall survival for contemporary melanoma patients is improved. This effect is driven by improvements for those with advanced stage disease, particularly those that received immunotherapy and BRAF/MEK targeted therapies.
Authors
Farrow, NE; Turner, MC; Salama, AKS; Beasley, GM
MLA Citation
Farrow, Norma E., et al. “Overall Survival Improved for Contemporary Patients with Melanoma: A 2004-2015 National Cancer Database Analysis.Oncol Ther, vol. 8, no. 2, Dec. 2020, pp. 261–75. Pubmed, doi:10.1007/s40487-020-00117-1.
URI
https://scholars.duke.edu/individual/pub1452786
PMID
32700043
Source
pubmed
Published In
Oncol Ther
Volume
8
Published Date
Start Page
261
End Page
275
DOI
10.1007/s40487-020-00117-1

The utility of initial staging PET-CT as a baseline scan for surveillance imaging in stage II and III melanoma.

BACKGROUND: This study evaluates the utility of whole-body PET-CT for the initial staging and subsequent surveillance imaging of patients with completely resected stage II and stage III melanoma. METHODS: A single-center, retrospective review of patients who received perioperative whole-body PET-CT from January 1, 2005 to December 1, 2019 within three months of initial melanoma diagnosis was performed. RESULTS: Of 258 total patients with completely resected melanoma who had a PET-CT within 3 months after their melanoma diagnosis, 113 had stage II and 145 had stage III melanoma. PET-CT detected distant metastasis in 3 (2.7%) of 113 stage II patients and 7 (4.8%) of 145 stage III patients. 179 of 258 patients had adequate follow-up time to determine whether they received surveillance cross-sectional imaging and whether they had a melanoma recurrence. 143 (79.9%) received subsequent surveillance imaging, 74 of whom developed a recurrence. In 64 (86.5%) of 74 cases, recurrence was detected by routine surveillance. 26 (34.2%) of 76 stage II and 65 (63.1%) of 103 stage III patients developed a recurrence. The median time to recurrence among the 179 patients for stage II and III was 16.3 and 13.0 months, respectively. CONCLUSIONS: These findings indicate that baseline staging with whole-body PET-CT rarely provides information that changes initial management. Rather, the value of the initial PET-CT is as a baseline for subsequent surveillance scans. Therefore, it may be premature to discourage cross-sectional imaging for patients with stage II and III melanoma without supportive evidence or a reliable biomarker of recurrent disease.
Authors
Ravichandran, S; Nath, N; Jones, DC; Li, G; Suresh, V; Brys, AK; Hanks, BA; Beasley, GM; Salama, AKS; Howard, BA; Mosca, PJ
MLA Citation
Ravichandran, Surya, et al. “The utility of initial staging PET-CT as a baseline scan for surveillance imaging in stage II and III melanoma.Surg Oncol, vol. 35, Dec. 2020, pp. 533–39. Pubmed, doi:10.1016/j.suronc.2020.10.018.
URI
https://scholars.duke.edu/individual/pub1464487
PMID
33161362
Source
pubmed
Published In
Surg Oncol
Volume
35
Published Date
Start Page
533
End Page
539
DOI
10.1016/j.suronc.2020.10.018

Dabrafenib and Trametinib in Patients With Tumors With BRAFV600E Mutations: Results of the NCI-MATCH Trial Subprotocol H.

PURPOSE: BRAFV600 mutations are commonly found in melanoma and thyroid cancers and to a lesser degree in other tumor types. Subprotocol H (EAY131-H) of the NCI-MATCH platform trial sought to investigate the selective BRAF inhibitor dabrafenib and the MEK1/2 inhibitor trametinib in patients with solid tumors, lymphomas, or multiple myeloma whose tumors harbored a BRAFV600 mutation. PATIENTS AND METHODS: EAY131-H is an open-label, single-arm study. Patients with melanoma, thyroid, or colorectal cancer were excluded; patients with non-small-cell lung cancer were later excluded in an amendment. Patients received dabrafenib 150 mg twice per day and trametinib 2 mg per day continuously until disease progression or intolerable toxicity. The primary end point was centrally assessed objective response rate (ORR); secondary end points included progression-free survival (PFS), 6-month PFS, and overall survival. RESULTS: Thirty-five patients were enrolled, and 29 were included in the primary efficacy analysis as prespecified in the protocol. Median age was 59 years, and 45% of the patients had received ≥ 3 lines of therapy. The confirmed ORR was 38% (90% CI, 22.9% to 54.9%) with P < .0001 against a null rate of 5%, and PFS was 11.4 months (90% CI, 8.4 to 16.3 months); responses were seen in 7 distinct tumor types. Seven patients had a duration of response of > 12 months, including 4 patients with a duration of response of > 24 months. An additional 8 patients had a PFS > 6 months. The median overall survival was 28.6 months. Reported adverse events were comparable to those noted in previously reported profiles of dabrafenib and trametinib. CONCLUSION: This study met its primary end point, with an ORR of 38% (P < .0001) in this mixed histology, pretreated cohort. This promising activity warrants additional investigations in BRAFV600-mutated tumors outside of currently approved indications.
Authors
Salama, AKS; Li, S; Macrae, ER; Park, J-I; Mitchell, EP; Zwiebel, JA; Chen, HX; Gray, RJ; McShane, LM; Rubinstein, LV; Patton, D; Williams, PM; Hamilton, SR; Armstrong, DK; Conley, BA; Arteaga, CL; Harris, LN; O'Dwyer, PJ; Chen, AP; Flaherty, KT
MLA Citation
Salama, April K. S., et al. “Dabrafenib and Trametinib in Patients With Tumors With BRAFV600E Mutations: Results of the NCI-MATCH Trial Subprotocol H.J Clin Oncol, vol. 38, no. 33, Nov. 2020, pp. 3895–904. Pubmed, doi:10.1200/JCO.20.00762.
URI
https://scholars.duke.edu/individual/pub1454553
PMID
32758030
Source
pubmed
Published In
Journal of Clinical Oncology
Volume
38
Published Date
Start Page
3895
End Page
3904
DOI
10.1200/JCO.20.00762