Assutina Sacco
· M.D.University of California, San Diego · Hematology and Medical Oncology
Active 2005–2025
About
Assuntina Sacco is a Clinical Professor of Medicine at UCSD, with a focus on hematology-oncology and bone marrow transplantation. Her research involves clinical trials and the development of treatment strategies for head and neck cancers, including radiotherapy, chemoradiotherapy, and immunotherapy. She has contributed to numerous studies on head and neck squamous cell carcinoma, exploring treatment deintensification, survival outcomes, and the management of recurrent or metastatic disease. Her work also encompasses the evaluation of novel therapeutic combinations, the use of circulating tumor DNA for disease monitoring, and the impact of treatment delays and sex-specific survival differences. Sacco's research aims to redefine treatment candidates and improve outcomes for patients with head and neck cancers through interdisciplinary approaches and clinical trials.
Research topics
- Medicine
- Computer Science
- Surgery
- Medical physics
- Family medicine
- Internal medicine
- Oncology
- Nursing
- Physical therapy
- Pathology
Selected publications
Journal of Clinical Oncology · 2025-05-28 · 8 citations
article6017 Background: HPV-negative head and neck squamous cell carcinoma (HNSCC) is an aggressive disease characterized by high recurrence, metastasis (R/M), and resistance to standard treatments. While anti–PD-1 therapies have improved outcomes, the prognosis for R/M HNSCC remains poor, necessitating novel approaches to achieve deeper, more durable responses and improved overall survival (OS). Ficerafusp alfa is a first-in-class bifunctional antibody targeting EGFR and TGF-β. Methods: This single-arm, multicenter, dose expansion of an ongoing phase 1/1b study (NCT04429542) enrolled patients (pts) aged ≥18 years with treatment-naive, unresectable R/M HNSCC, with a CPS ≥1. Pts received ficerafusp alfa (1500 mg IV on days 1, 8, and 15) combined with pembrolizumab (200 mg IV on day 1) every 21 days. Study objectives included objective response rate (ORR) per RECIST v1.1, duration of response (DOR), progression-free survival (PFS), OS, safety (CTCAE v5), and pharmacodynamic analyses. This report presents updated findings after two years of follow-up. Results: As of December 16, 2024, 42 pts were treated (71% male, median age: 63 years [range: 31–84]); 39 were efficacy evaluable (EE). Among the EE pts, the ORR was 54% (21/39; 95% CI: 37–70) in the overall cohort and 64% (18/28; 95% CI: 44–81) in HPV-negative pts. Notably, 21.4% of HPV-negative pts achieved a complete response (CR). A confirmed durable response of ≥6 and ≥12 months was observed in 72% (13/18) and 56% (10/18) of overall and 73% (11/15) and 60% (9/15) of HPV-negative responders, respectively. Median PFS was 7.4 months (95% CI: 2.9–14.5 overall, and 9.8 months (95% CI: 4.4–23.2) in the HPV-negative subgroup. The 12-month OS rate was 61.5% (95% CI: 44.5–75.7) across the cohort and 60.7% (95% CI: 40.4–76.0) for HPV-negative pts. At data cutoff, all evaluable pts had been followed for at least 20 months. Median OS and DOR had not been reached yet in HPV-negative pts, with mOS surpassing 20 months. Safety findings were consistent with the known safety profile of ficerafusp alfa plus pembrolizumab, while pharmacodynamic analyses demonstrated encouraging post-treatment downregulation of pSMAD2 supporting targeted TGF-β inhibition. Conclusions: Ficerafusp alfa combined with pembrolizumab continues to show promising efficacy relative to historical data on the current standard of care, particularly in HPV-negative HNSCC. Median PFS and 12-month OS, ORR, and CR rates are encouraging relative to historical benchmarks in pts with HPV-negative HNSCC. 24-month OS and mature OS/DOR outcomes are anticipated. These findings provide compelling rationale for FORTIFI-HN01, the ongoing multicenter, randomized, double-blind phase 2/3 clinical trial evaluating this combination in first-line PD-L1–positive, HPV-negative R/M HNSCC. Clinical trial information: NCT04429542 .
Journal of Clinical Oncology · 2025-05-28 · 10 citations
article6024 Background: EGFR is a known oncogenic driver in HNSCC, and the leucine-rich repeat-containing G-protein coupled receptor 5 (LGR5) is associated with cancer stem cells in solid tumors and expressed in HNSCC. Petosemtamab is a human, common light chain, IgG1 bispecific antibody with ADCC-enhanced activity, targeting EGFR and LGR5. Promising interim data from this phase 2, single-arm trial of petosemtamab 1500 mg every 2 weeks (Q2W; 28-day cycles) with pembrolizumab (400 mg Q6W) as 1L treatment in PD-L1+ HNSCC (NCT03526835) demonstrated a 67% overall response rate (ORR) in 24 efficacy evaluable patients (pts) [Fayette, ASCO 2024]. Methods: Primary endpoints are investigator-assessed ORR (RECIST v1.1) and safety. Secondary endpoints include duration of response (DOR), progression-free survival (per investigator), and overall survival (OS). Key eligibility criteria were r/m HNSCC with no prior systemic therapy in the r/m setting, PD-L1 combined positive score ≥1, ECOG PS 0–1, measurable disease, and primary tumor location in oropharynx (regardless of p16 status), oral cavity, hypopharynx, or larynx. Results: A total of 45 pts were treated; as of a September 16, 2024 data cutoff, 18 pts continuing on therapy. Median age was 64 years (range 23–80), ECOG PS 0/1 in 16/29 pts, and 78% were male. The most frequent primary tumor locations were oropharynx (31%), oral cavity (31%), larynx (16%), and hypopharynx (11%). A median of 8 cycles (range 1–17) were administered. Among 43 pts evaluable for efficacy (pts with ≥1 dose and ≥1 post-baseline scan, or who discontinued early due to progressive disease or death), the ORR was 60% (26/43) with 5 complete responses; median DOR was 11 months with 17 responders still on treatment at data cutoff. Of the 8 pts with p16+ oropharyngeal disease, 4 had confirmed responses (ORR 50%). The median follow-up for OS was 9.6 months; median OS was not reached. Kaplan–Meier estimate of OS at 6 months was 93%. The combination was well tolerated, and no significant overlapping toxicities were observed. Treatment-emergent adverse events (AEs) were reported in 45 pts, most were Grade (G) 1 or 2 in severity; one previously reported unrelated G5 AE occurred. The most frequent AEs (all G/G≥3) were acneiform dermatitis (49%/7%), asthenia (49%/7%), and rash (44%/0%). Infusion-related reactions (composite term) were reported in 38% (all G) and 7% (G3) of pts, mainly occurred at first infusion, and all resolved. Updated data to be presented. Conclusions: Petosemtamab, a first-in-class EGFR x LGR5 bispecific antibody, in combination with pembrolizumab continues to demonstrate promising clinical efficacy and a well-tolerated safety profile as 1L treatment for pts with r/m PD-L1+ HNSCC. A global phase 3 trial, LiGeR-HN1 (NCT06525220), is ongoing to evaluate petosemtamab in combination with pembrolizumab in 1L PD-L1+ r/m HNSCC. Clinical trial information: NCT03526835 .
The Lancet Oncology · 2024-11-14 · 53 citations
articleOpen access<h2>Summary</h2><h3>Background</h3> Management of patients with locoregionally advanced head and neck squamous cell carcinoma (HNSCC) when cisplatin is contraindicated is controversial. We aimed to assess whether radiotherapy with concurrent and adjuvant durvalumab would improve outcomes compared with radiotherapy with cetuximab. <h3>Methods</h3> NRG-HN004 was designed as an open-label, multicentre, parallel-group, randomised, phase 2/3 trial with safety lead-in conducted at 89 academic and community medical centres in North America. Eligible patients were aged 18 years or older with American Joint Committee on Cancer 8th edition stage III–IVB p16-negative HNSCC or unfavourable stage I–III p16-positive oropharyngeal or unknown primary carcinoma, who had a contraindication to cisplatin (Eastern Cooperative Oncology Group [ECOG] performance status 2, renal or hearing impairment, peripheral neuropathy, aged at least 70 years with moderate or severe comorbidity, or aged younger than 70 years with severe comorbidity). Patients were randomly assigned (2:1) by permuted block randomisation (multiples of 6) to intravenous durvalumab 1500 mg starting 2 weeks before radiotherapy then every 4 weeks starting week 2 of radiotherapy (seven cycles) or intravenous cetuximab 400 mg/m<sup>2</sup> 1 week before radiotherapy then 250 mg/m<sup>2</sup> weekly beginning week 1 of radiotherapy (eight cycles), with intensity-modulated radiotherapy (70 Gy in 35 fractions over 7 weeks). Stratification factors were tumour and nodal stage, ECOG performance status and comorbidity, and primary site and p16 status. The phase 2 primary endpoint was progression-free survival in the intention-to-treat population. There was one prespecified interim futility analysis at 50% of progression-free survival information. If the observed hazard ratio was 1·0 or more, favouring cetuximab, early stopping would be considered. Extended follow-up analysis was post hoc. This trial is registered with ClinicalTrials.gov, NCT03258554, and is closed to enrolment. <h3>Findings</h3> Following a ten-patient safety lead-in, the phase 2 trial enrolled 190 patients from March 12, 2019, to July 30, 2021, 186 of whom were randomly assigned (123 to durvalumab and 63 to cetuximab). Median age was 72 years (IQR 64–77), 30 (16%) patients were women and 156 (84%) were men. Phase 2 accrual was suspended in July 30, 2021, following an interim futility analysis, and permanently closed in Sept 1, 2022. The phase 3 part of the trial was not conducted. At a median follow-up of 2·3 years (IQR 1·9–3·1) for the extended follow-up (data cutoff July 31, 2023; post-hoc analysis), 2-year progression-free survival was 50·6% (95% CI 41·5–59·8) in the durvalumab group versus 63·7% (51·3–76·1) in the cetuximab group (hazard ratio 1·33 [95% CI 0·84–2·12]; p=0·89). Adverse events were similar in both groups. The most common grade 3–4 adverse events were dysphagia (26 [22%] of 119 patients in the durvalumab group <i>vs</i> 18 [30%] of 61 patients in the cetuximab group), lymphopenia (33 [28%] <i>vs</i> 20 [33%]), and oral mucositis (13 [11%] <i>vs</i> 11 [18%]). Four (3%) patients in the durvalumab group and one (2%) in the cetuximab group died from treatment-related adverse events (death not otherwise specified, laryngeal oedema, lung infection, and respiratory failure in the durvalumab group and sudden death not otherwise specified in the cetuximab group). <h3>Interpretation</h3> Our findings suggest that durvalumab did not improve outcomes compared with cetuximab in patients with HNSCC with contraindications to cisplatin. Further trials are needed to define the standard of care for this population. <h3>Funding</h3> US National Cancer Institute and AstraZeneca.
International Journal of Radiation Oncology*Biology*Physics · 2024-09-20 · 5 citations
articleSister partnership to overcome the global burden of cancer
British Journal of Radiology · 2024-09-05 · 2 citations
reviewOpen accessEmerging countries are currently facing an increasing burden of cancer while they do not have adequate prevention, monitoring, and research capabilities to tackle the disease. Cancer outcomes are influenced by several factors, including different cancer patterns, national cancer screening guidelines, current stage of disease, and access to quality care and treatments. Discrepancies in cancer care between emerging and developed countries require actions to achieve global health equity. The process of pioneering a sister relationship in the oncology field can thwart the global burden of cancer. The objective of such cooperation programs should include research and training programs, evidence-based oncology practice, and quality cancer. Building global connections will therefore be the novel approach to addressing the global burden of cancer.
Academic Radiology · 2024-03-23 · 1 citations
articleOpen accessAnnals of Oncology · 2024-12-01 · 8 citations
articleOpen accessSex‐Specific Survival and Treatment Delay in Oropharyngeal Squamous Cell Carcinoma
Otolaryngology · 2024-04-28 · 6 citations
articleOpen accessOBJECTIVE: As the majority of oropharyngeal squamous cell carcinoma (OPSCC) is diagnosed in males, outcomes among females are not well-characterized. We identify sex-specific factors in OPSCC to refine female prognostication. STUDY DESIGN: Retrospective cohort. SETTING: National Cancer Database (NCDB). METHODS: OPSCC cases from the 2004 to 2019 NCDB were identified. Sociodemographic, clinical, and treatment characteristics (including timing between diagnosis and treatment administration) were compared between sexes. Multivariable Cox proportional hazard regression models were constructed to characterize survival in overall and female-only cohorts. Similar multivariable binomial logistic regression and survival models were constructed to assess odds of treatment delays and their effects on survival, respectively. RESULTS: A total of 192,973 OPSCC patients were identified; 36,695 (19%) were female. Females had more human papillomavirus (HPV) negative, lower clinical T and N stage, and higher comorbidity disease. Females experienced lower survival in HPV negative (hazard ratio, HR = 1.11, P < .001) but not HPV-positive disease. Females were more likely to have any treatment initiated over the median of 28 days (odds ratio, OR = 1.04, P = .014) or delays in adjuvant radiotherapy initiation over 6 weeks (OR = 1.11, P = .032). Treatment delay over 60 days (HR = 1.17, P = .016) and delay in adjuvant therapy initiation (HR = 1.24, P = .02) were associated with worse survival among females. CONCLUSION: In one of the largest analyses of OPSCC, females had poorer survival than males, specifically in HPV-negative disease, despite presentation with less advanced disease. Notably, delays in any treatment initiation and adjuvant radiotherapy initiation were more likely in HPV-negative women and associated with worse survival, highlighting potential systemic weaknesses contributing to poor prognosis among females.
International Journal of Radiation Oncology*Biology*Physics · 2024-03-14 · 9 citations
articleJournal of Clinical Oncology · 2024-06-01 · 18 citations
article6014 Background: EGFR is a known oncogenic driver in HNSCC, and the leucine-rich repeat-containing G-protein coupled receptor 5 (LGR5) is a receptor expressed on cancer stem cells, including in HNSCC. Petosemtamab is a human, common light chain, IgG1 bispecific antibody with ADCC-enhanced activity, targeting EGFR and LGR5. In the dose escalation part of a phase 1/2 study, the recommended phase 2 dose (RP2D) was determined to be 1500 mg every 2 weeks (Q2W). Interim data of petosemtamab monotherapy at the RP2D in 2L/3L HNSCC led to a 37.2% overall response rate (ORR; per investigator) with 6.0 months (mo) median duration of response (DOR) [Cohen, Cancer Research 2023]. Petosemtamab (RP2D) with pembrolizumab (400 mg Q6W) is being investigated in an expansion cohort of the ongoing phase 2 study (NCT03526835) in 1L HNSCC. Methods: Primary endpoints are safety and investigator-assessed ORR (RECIST v1.1). Secondary endpoints include DOR, progression-free survival (per investigator), and overall survival. Key eligibility criteria were r/m HNSCC with no prior systemic therapy, PD-L1 combined positive score ≥1, ECOG PS 0–1, measurable disease, and primary tumor location in oropharynx (regardless of p16 status), oral cavity, hypopharynx, or larynx. Results: No dose-limiting toxicities were observed in the safety run-in. As of a November 6, 2023 data cutoff, 26 pts were treated (24 continuing therapy at the data cutoff) and median follow-up was 1.35 mo. Median age was 62.5 years (range 23–80), ECOG PS 0/1 in 10/16 pts, and 65.4% were male. The most frequent primary tumor locations were oropharynx (34.6%), oral cavity (19.2%), and hypopharynx (19.2%). A median of 2 cycles (range 1–8) were administered. The combination was well tolerated and no significant overlapping toxicities were observed. Treatment-emergent adverse events (AEs) were reported in 26 pts, and most were Grade (G) 1 or 2 in severity (no G4–5 were observed). The most frequent AEs (all Gs/G3) were acneiform dermatitis (30.8%/0%), asthenia (26.9%/0%), and rash (26.9%/0%). Infusion-related reactions (composite term) were reported in 26.9% (all Gs) and 3.8% (G3) of pts, all occurred during the first infusion and resolved. Among 10 pts evaluable for efficacy (≥2 cycles and ≥1 post-baseline scan, or early progressive disease), there were 1 confirmed complete response, 2 confirmed and 3 unconfirmed partial responses (2 confirmed after data cutoff), 3 stable disease, and 1 progressive disease; with all 6 responders on treatment at data cutoff. Enrollment has been completed and updated data will be presented. Conclusions: Petosemtamab, a first-in-class EGFR x LGR5 bispecific antibody, in combination with pembrolizumab demonstrates a well-tolerated safety profile and promising preliminary clinical efficacy as 1L treatment for pts with r/m HNSCC. Clinical trial information: NCT03526835 .
Frequent coauthors
- 36 shared
Gregory A. Daniels
University of California, San Diego
- 35 shared
Douglas B. Chepeha
University of Michigan–Ann Arbor
- 30 shared
Ezra E.W. Cohen
Tempus Labs (United States)
- 29 shared
Francis P. Worden
- 22 shared
Mark E. Prince
- 21 shared
Gregory T. Wolf
University of Michigan–Ann Arbor
- 21 shared
Carol R. Bradford
- 21 shared
Sandip Pravin Patel
University of California, San Diego
Education
- 1994
Ph.D., Molecular and Cell Biology
University of California, San Diego
- 1990
M.S., Molecular and Cell Biology
University of California, San Diego
- 1988
B.S., Biology
University of California, San Diego
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