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Clinical

Karen M. Winkfield, MD, PhD; Narjust Florez, MD, FASCO; Gilberto de Lima Lopes Junior, MD, MBA, FASCO; Coral Olazagasti, MD; Vonetta M. Williams, MD, PhD

 Fighting Disparities and Saving Lives: An Exploration of Challenges and Solutions in Cancer Care

During a live event, Deborah Wong, MD, PhD, discussed the role of PD-1 inhibitors in nasopharyngeal cancer and their accessibility/safety.

Participants Discuss Optimal Immunotherapy Choices for Metastatic NPC

Nivolumab with cisplatin and radiotherapy improved disease-free survival in high-risk locally advanced squamous cell carcinoma of the head and neck in the NIVOPOSTOP trial.

Nivolumab Boosts DFS in High-Risk LA-SCCHN Post Surgery

During a live event, Deborah Wong, MD, PhD, discussed the role of EBV and challenges in nasopharyngeal cancer diagnosis with event participants.

Challenges Considered for Diagnosing Nasopharyngeal Cancer

Reduced-dose radiotherapy in head & neck cancer shows similar efficacy to standard dose but with lower toxicity, per findings from the UPGRADE-RT trial. 

Reduced-Dose RT Safe & Effective for Head & Neck Cancer, Lowering Toxicity 

Pembrolizumab combo before/after surgery and radiation significantly improved event-free survival in resectable advanced head and neck cancer per KEYNOTE-689, introducing a potential new standard of care. 

Keytruda Plus SOC: New Standard for Advanced Head & Neck Cancer

After the FDA Approval: Next Steps for Penpulimab in NPC

 for first-line treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC) as a single agent and in combination with cisplatin or carboplatin and gemcitabine in April 2025. In an interview with 

, assistant professor, Department of Medical Oncology & Therapeutics Research, at City of Hope and an investigator of the phase 3 Study AK105-304 (NCT04974398) that supported the approval, discusses the benefits penpulimab offers over the standard of care and where research is headed for this agent.

While cross-trial comparisons should be interpreted cautiously, the hazard ratio for progression-free survival in this study was notably impressive at 0.45, appearing slightly better than some other agents in this setting. Additionally, the rate of grade 3 immune-related adverse events was lower at 4.1% compared with what was observed with toripalimab (Loqtorzi) in the JUPITER-02 study (NCT03581786). These aspects are particularly noteworthy, according to Shreenivas.

Furthermore, this was a truly global study, unlike JUPITER-02 which included no non-Asian patients and lacked a crossover design. Offering a crossover option in contemporary trials is often preferred and receives greater support from patient groups, Shreenivas explained. 

This study was funded and supported by Akeso Bio, a China-based company developing multiple compounds. Future research could explore novel combinations with penpulimab to further improve response rates and progression-free survival. 

Interestingly, Shreenivas notes that PD-L1 did not appear to be the most effective predictive marker in this study, as responses were observed across different PD-L1 levels. Therefore, identifying more informative biomarkers to better select patients for these combination therapies is crucial. Analyzing historical factors like metastasis sites and EBV DNA from the subgroup analysis could yield further insights. It's also important to note that overall survival data is not yet available from this crossover study, making the mature OS results highly anticipated.

"I would like to thank all the investigators who are involved, all patients that were involved with this study and Akeso Bio, and also my home institution, City of Hope," Shreenivas added in the interview. 

Videos

Aditya Shreenivas, MD, MS, discusses the clinical trial that led to the FDA approval of penpulimab in nasopharyngeal carcinoma. 

Global Study Supports Penpulimab for First-Line Recurrent NPC

, Aditya Shreenivas, MD, MS, assistant professor, Department of Medical Oncology & Therapeutics Research, at City of Hope and an investigator of the phase 3 Study AK105-304 (NCT04974398) that supported the approval, discusses the study's design and its findings. 

According to Shreenivas, this was a randomized Phase 3 study evaluating penpulimab plus chemotherapy versus chemotherapy and placebo as a first-line treatment for NPC. Previously, toripalimab (Loqtorzi) was the only FDA-approved agent in this setting. While other studies like JUPITER-02 (NCT03581786), CAPTAIN-1st (NCT03707509), and RATIONALE-309 had explored other agents, these were primarily conducted in Asia. This penpulimab study is notable for being a truly global trial, including sites in South America, the US, and Canada. Although enrollment was lower in non-Asian countries due to the lower incidence of NPC, the study played a crucial role in demonstrating the drug's efficacy outside of Asia.

The primary endpoint of this study, progression-free survival (PFS), was met at the interim analysis with statistical significance. The median PFS was 9.6 months in the penpulimab plus chemotherapy arm compared with 7 months in the placebo plus chemotherapy arm. Patients in the experimental arm also experienced a longer duration of response (9.8 months vs 5.6 months). The hazard ratio for PFS was 0.45, indicating a 55% reduction in the risk of disease progression.

The safety profile of the combination was manageable. Grade 3 or higher hematological toxicities were similar in both arms. Notably, the incidence of immune-related adverse events was low at 4.1%, potentially due to the agent's Fc-null function, which may mitigate these side effects. This manageable safety profile suggests broader applicability.

Furthermore, prespecified subgroup analyses demonstrated consistent efficacy across various subgroups, including patients with high or low PD-L1 expression, the presence or absence of liver metastases, and high or low EBV DNA levels.

"It's also important to note that this study has not given us the overall survival analysis. This was a crossover study, unlike some of the other studies in this space. It would be nice to see when the mature overall survival data is available," Shreenivas added in the interview. 

Aditya Shreenivas, MD, MS, discusses findings from the clinical trial supporting the FDA approval of penpulimab in nasopharyngeal carcinoma. 

Deborah Wong, MD, PhD, discusses the toripalimab combination that is now considered standard of care in nasopharyngeal cancer.

Toripalimab Combo Delivers Long-Term Efficacy in Nasopharyngeal Cancer

Deborah Wong, MD, PhD, associate clinical professor in the Department of Medicine, Division of Hematology-Oncology and director of the Head and Neck Medical Oncology Program at the University of California, Los Angeles, discusses the toripalimab (Loqtorzi) combination that is now considered standard of care in nasopharyngeal cancer (NPC).

The FDA approved gemcitabine, cisplatin, and toripalimab for first-line treatment in patients with recurrent and metastatic nasopharyngeal cancer. This was based on a double-blinded, randomized phase 3 trial called JUPITER-02 (NCT03581786). In the study, 289 patients were randomly assigned to receive gemcitabine/cisplatin plus placebo vs gemcitabine/cisplatin plus toripalimab.

This trial demonstrated a significantly improved progression-free survival (PFS) in patients with NPC receiving toripalimab. The median overall survival (OS) for the toripalimab group had not been reached in the initial read-out of the data. Recent follow-up data further supported these findings, establishing the combination of gemcitabine, cisplatin, and toripalimab as the new standard of care, according to Wong.

 This gemcitabine, cisplatin, toripalimab combination, which has been approved for frontline treatment of recurrent and metastatic nasopharyngeal cancer, was approved by the FDA based on a large phase 3, double-blinded, randomized study called JUPITER-02. This was published in 2023 initially, and in this study, 289 patients were [randomly assigned] to receive either gemcitabine and cisplatin, which was the prior standard of care, with placebo or gemcitabine, cisplatin, and toripalimab. Randomization was 1:1, and these patients received 6 cycles of chemotherapy with either placebo or toripalimab. Following this, patients continued with maintenance toripalimab or placebo, depending on which arm of the study they were randomized to. Treatment continued until 2 years of therapy or until progression of disease or unacceptable toxicity.

 The data from JUPITER-02 were very impressive, in which at the final analysis from the initial publication, PFS was significantly improved in the patients who received toripalimab. Specifically, the median PFS was 21.4 months vs 8.2 months, with an HR of 0.52. At the time of the initial publication or the initial analysis of the phase 3 data, median OS for the group receiving toripalimab had not yet been reached, whereas it was 33.7 months for placebo. That was statistically significant as well.

 There have been follow-up survival data that have been published recently in the [

] this past year, in which you do see a continued separation of the survival curves in favor of the arm containing toripalimab. Based on these impressive data, the frontline standard of care for recurrent and metastatic nasopharynx cancer is gemcitabine, platinum, and toripalimab.

Discussing Upcoming Data and Key Takeaways in Head and Neck Cancer

In this video, Trisha Wise-Draper, MD, PhD, discusses upcoming data eagerly awaited from the phase 3 KEYNOTE-689 (NCT03765918) and phase 3 NIVOPOSTOP (NCT03576417) trials, evaluating cancers of the head and neck and what these data could mean for the field.

In the open-label KEYNOTE-689 trial, investigators are evaluating the efficacy and safety of neoadjuvant and adjuvant pembrolizumab (Keytruda) in combination with standard-of-care (SOC) radiotherapy with or without cisplatin in treatment-naïve, high-risk, resectable, locally advanced (LA) head and neck squamous cell carcinoma (HNSCC).

 Patients with newly diagnosed LA HNSCC are randomly assigned 1:1 to receive the experimental combination, which includes pembrolizumab 200 mg every 3 weeks for 2 cycles, then surgical resection, and then SOC plus adjuvant pembrolizumab for 15 cycles, or undergo surgical resection followed by adjuvant SOC.

In the open label, randomized, controlled, multicenter NIVOPOSTOP study, investigators are evaluating the efficacy and reduction of toxicity for nivolumab (Opdivo) in combination with SOC.

 Patients with LA SCCHN, exhibiting extra capsular extension and/or high risk are randomly assigned 1:1 to receive post-operative nivolumab in combination with 3 cycles of cisplatin during radiation therapy or concomitant cisplatin with radiation therapy.

Wise-Draper, professor of medicine in the Division of Hematology/Oncology and section head of medical oncology at UC Health, Ohio, is very “excited about the neoadjuvant radiation studies.” Radiation can be very difficult especially after surgery, Wise-Draper explains and hopes that this approach will provide some relief to patients in addition to survival benefit.

“If you are going to give [immunotherapy] in the curative setting, whether it is definitive or surgical, I would hesitate—unless you have a clinical trial—until we have a little bit more information. We are hoping American Association for Cancer Research and American Society of Clinical Oncology, will give us a little bit more data on whether it is a good idea to give immunotherapy before surgery,” Wise-Draper explains.

1. Ravindra Uppaluri, Lee NY, Westra WH, et al. KEYNOTE-689: phase 3 study of adjuvant and neoadjuvant pembrolizumab combined with standard of care (SOC) in patients with resectable, locally advanced head and neck squamous cell carcinoma. 

. 2019;37(15_suppl):TPS6090-TPS6090. doi.org/10.1200/jco.2019.37.15_suppl.tps6090

2. A trial evaluating the addition of nivolumab to cisplatin-RT for treatment of cancers of the head and neck (NIVOPOSTOP). ClinicalTrials

gov. Updated July 5, 2024. Accessed March 27, 2025. https://clinicaltrials.gov/study/NCT03576417

3. Plavc G, Strojan P. Combining radiotherapy and immunotherapy in definitive treatment of head and neck squamous cell carcinoma: review of current clinical trials. 

. 2020;54(4):377-393. October 11, 2020. doi:10.2478/raon-2020-0060

Trisha Wise-Draper, MD, PhD, discusses anticipated data on head and neck cancers and their potential impact on the field.

News

Recent Failures Spur Innovation in Head and Neck Cancer Trials

After unfavorable results from the phase 3 KEYNOTE-412 (NCT03040999) and JAVELIN Head and Neck 100 (NCT02952586) trials in head and neck cancers, researchers analyzed the results to develop their next moves. To enhance outcomes emerging new trial designs are already showing improvement.

In this video, Trisha Wise-Draper, MD, PhD, professor of medicine in the Division of Hematology/Oncology and section head of medical oncology at UC Health, Ohio, provides an overview of the advancements for the management of head and neck cancers.

“There were a lot of questions about those studies and why they might have failed. Some [surmise] that it may have been just the timing,” Wise -Draper explains regarding the KEYNOTE-412 and JAVELIN Head and Neck 100 studies. “There have been subsequent studies, at least in the adjuvant setting, that sequence the pembrolizumab or PD-1 inhibitor after the radiation, instead of concurrently. This may be a better sequential way of doing it to enhance the immune response, rather than doing concurrent treatment.”

She explains that phase 2 trials, one conducted by herself and one by Ravindra Uppaluri, MD, PhD, director of Head and Neck Surgical Oncology at the Brigham and Women’s Hospital and Dana-Farber Cancer Institute in Boston, explored treatment in the neoadjuvant setting.

 In these trials, investigators evaluated neoadjuvant immunotherapy as a monotherapy followed by immunotherapy plus radiation and chemotherapy or radiation alone. These landmark trials await being presented at upcoming conferences.

Next steps include separating neoadjuvant and adjuvant approaches to better understand their benefit and understand the importance of pathological response for this cancer type, Wise-Draper explains.

1. Lee NY, Ferris RL, Psyrri A, et al. Avelumab plus standard-of-care chemoradiotherapy versus chemoradiotherapy alone in patients with locally advanced squamous cell carcinoma of the head and neck: a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial. 

. 2021;22(4):450-462. doi:10.1016/S1470-2045(20)30737-3

2. Machiels JP, Tao Y, Licitra L, et al. Pembrolizumab plus concurrent chemoradiotherapy versus placebo plus concurrent chemoradiotherapy in patients with locally advanced squamous cell carcinoma of the head and neck (KEYNOTE-412): a randomised, double-blind, phase 3 trial. 

. 2024;25(5):572-587. doi:10.1016/S1470-2045(24)00100-1

3. Wise-Draper TM, Gulati S, Palackdharry S, et al. Phase II clinical trial of neoadjuvant and adjuvant pembrolizumab in resectable local-regionally advanced head and neck squamous cell carcinoma. 

. 2022;28(7):1345-1352. doi:10.1158/1078-0432.CCR-21-3351

4. Uppaluri R, Campbell KM, Egloff AM, et al. Neoadjuvant and adjuvant pembrolizumab in resectable locally advanced, human papillomavirus-unrelated head and neck cancer: a multicenter, phase II trial. 

 2020;26(19):5140-5152. doi:10.1158/1078-0432.CCR-20-1695

Trisha Wise-Draper, MD, PhD, provides an overview of the advancements for the management of head and neck cancers.

Deborah Wong, MD, PhD, discusses therapeutic options for patients with nasopharyngeal carcinoma.

Understanding Treatment Options in Nasopharyngeal Carcinoma

Deborah Wong, MD, PhD, associate clinical professor in the Department of Medicine, Division of Hematology-Oncology and director of the Head and Neck Medical Oncology Program at the University of California, Los Angeles, discusses therapeutic options for patients with nasopharyngeal carcinoma.

This rare head and neck cancer is often linked to the Epstein–Barr virus, typically presenting with locally advanced disease. This will many times involve a tumor in the nasopharynx that could possibly spread to neck lymph nodes. Standard treatment involves induction chemotherapy with gemcitabine and cisplatin followed by chemotherapy with radiation, curing many patients, according to Wong.

However, some patients relapse or present with de novo metastatic disease. For those not recently exposed to platinum-based therapies, the standard of care includes gemcitabine, cisplatin, and the anti-PD-1 immunotherapy toripalimab-tpzi (Loqtorzi), to manage or potentially cure metastatic cases.

 Nasopharyngeal carcinoma is a relatively rare subgroup of head and neck cancers, and many of these are driven by a virus called Epstein–Barr virus. Most patients will present with locally advanced disease, meaning a tumor in their nasopharynx and potentially spread to the lymph nodes in the neck. In that setting, the standard treatment is usually to treat with induction chemotherapy with gemcitabine and cisplatin. Following induction chemotherapy, patients receive chemotherapy concurrence with radiation.

 A good number of patients will be cured with this approach. However, some patients will unfortunately relapse and develop a recurrent or metastatic disease. In addition, there are some patients who present with a de novo metastatic disease from nasopharyngeal cancer. For those patients who have not received gemcitabine and cisplatin recently, within the past 6 months or so, those patients are considered platinum sensitive, and the standard of care would be to treat with a combination of gemcitabine and platinum [chemotherapy], along with toripalimab, which is an anti–PD-1 immunotherapy.

Understanding Extranodal Extension in Head and Neck Cancer: New Imaging Guidelines Explained

Extranodal extension is an important prognostic factor in head and neck cancer. Imaging plays a crucial role in detecting extranodal extension. However, current guidelines often rely on clinical findings, which may overlook subtle cases.

Christina Henson, MD, discusses how new guidelines for head and neck cancer imaging could change dynamics for physicians and patients. 



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