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Barry Goy, MD, is a radiation oncologist at Kaiser Permanente Los Angeles Medical Center.

Barry Goy, MD, provides insight into the clinical implications of a retrospective analysis examining 15-year outcomes in patients with intermediate-risk prostate cancer.

Long-Term Outcomes of EBRT and Androgen Deprivation in Prostate Cancer

ASH 2024 Preview for Community Oncologists: The Show and After Show

The American Society of Hematology (ASH) Annual Meeting and Exposition aims to educate oncology providers across an array of hematologic malignancies, with a focus on novel agents, drugs across the FDA pipeline, and more.

, co-hosts Kristie L. Kahl and Andrew Svonavec offer a glimpse at some of the presentations guaranteed to spark one’s curiosity, spur debate, and enhance the field even further. Some key highlights include:

 Continued advancements in CAR T-cell therapy are expected to revolutionize the treatment of hematologic malignancies.

 Bispecific antibodies, such as Epcoritamab (Epkinly), offer a novel approach to target multiple antigens on cancer cells.

 The assessment of MRD is becoming increasingly important in predicting treatment response and overall survival.

Advances in Acute Lymphoblastic Leukemia (ALL)

Blinatumomab (Blincyto) in pediatric ALL:

 The addition of blinatumomab to chemotherapy has shown promise in improving disease-free survival in high-risk pediatric ALL. This combination therapy may offer a more effective treatment option for young patients.

Acalabrutinib (Calquence) in mantle cell lymphoma (MCL):

 The FDA is set to review the approval of acalabrutinib with bendamustine or rituximab (Rituxan) for previously untreated MCL, based on data from the phase 3 ECHO trial (NCT02972840).

Asciminib (Scemblix) in chronic phase chronic myelogenous leukemia (CML-CP):

 The FDA recently granted accelerated approval to asciminib for newly diagnosed CML-CP. This tyrosine kinase inhibitor has shown favorable safety and tolerability profiles.

 isn't just about data, as the duo also offers food recommendations, tourist attractions and fun activities to partake in, as well as interesting facts about San Diego.

This is just a taste of the wealth of information and inspiration waiting at the 2024 ASH Annual Meeting. Check back for future meeting previews with 

Targeted Oncology co-hosts Kristie L. Kahl and Andrew Svonavec highlight abstracts for community oncologists to look out for at the upcoming ASH Annual Meeting in San Diego, with some additional tidbits to round out the main event.

News

The biologics license application (BLA) of the subcutaneous formulation of nivolumab (Opdivo) coformulated with human hyaluronidase (rHuPH20) has been accepted by the FDA.

Findings from the CheckMate -67T (NCT04810078) support this BLA of subcutaneous nivolumab as the trial met its coprimary pharmacokinetic end points and key secondary end point of overall response rate (ORR) vs intravenous (IV) nivolumab in clear cell renal cell carcinoma.

The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date for December 29, 2024.

The FDA has accepted the BLA of the subcutaneous formulation of nivolumab coformulated with rHuPH20, also known as subcutaneous nivolumab, for all previously approved adult solid tumor indications of nivolumab as a monotherapy, monotherapy maintenance following completion of the combination therapy with nivolumab plus ipilimumab (Yervoy), or in combination with chemotherapy or cabozantinib (Cabometyx).

Results from the phase 3 CheckMate -67T trial of subcutaneous nivolumab support this application. In the trial, experts sought to evaluate subcutaneous nivolumab vs its intravenous (IV) formulation.

 Here, the subcutaneous form demonstrated noninferior pharmacokinetics and efficacy, as well as consistent safety compared with the IV formulation of nivolumab among patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior systemic therapy.

A PDUFA goal date has been set for December 29, 2024. With this, subcutaneous nivolumab shows promise to become the first and only subcutaneously administered PD-1 inhibitor.

“We believe subcutaneous nivolumab has the potential to make a significant difference in the lives of patients, which is reinforced by the FDA’s acceptance of our application,” said Gina Fusaro, PhD, vice president, global program lead, Bristol Myers Squibb, in a press release.

“[Nivolumab] is a foundational PD-1 inhibitor approved for many different types of cancer, and our continued investment in research that puts patients first remains a priority. If approved by the FDA, the subcutaneous administration of nivolumab would provide patients and their physicians with a new option that delivers the same well-known benefits as IV [nivolumab] but with the improved convenience of an injection administered in 3 to 5 minutes rather than a 30- to 60-minute infusion,” Fusaro continued.

The phase 3, randomized, open-label CheckMate -67T trial is exploring subcutaneous administration of nivolumab coformulated with rHuPH20 vs IV nivolumab for the treatment of patients with advanced or metastatic ccRCC who were previously treated with systemic therapy.

In the study, 495 patients were randomly assigned to receive either subcutaneous nivolumab or IV nivolumab. Enrollment was open to patients with a histological confirmation of ccRCC, advanced RCC not amenable to curative or radiation therapy, metastatic RCC, those who received no more than 2 prior systemic therapies, those with intolerance or progression after last treatment regimen within 6 months of randomization, and those with a Karnofsky performance score ≥ 70 at screening.

Experts assessed the coprimary end points of time-averaged serum concentration over 28 days and trough serum concentration at steady-state of subcutaneous nivolumab vs IV nivolumab. A key secondary end point of the trial was ORR.

The study met its coprimary pharmacokinetic end points and key secondary end point of ORR with subcutaneous nivolumab in this patient population.

 Subcutaneous nivolumab was noninferior in regard to time-averaged nivolumab serum concentration over 28 days and steady-state trough serum concentration vs treatment with IV nivolumab. Additionally, subcutaneous nivolumab also demonstrated a noninferior ORR compared with IV nivolumab.

1. U.S. Food and Drug Administration accepts Bristol Myers Squibb’s application for subcutaneous nivolumab (nivolumab and hyaluronidase). News release. Bristol Myers Squibb. May 6, 2024. Accessed May 6, 2024. 

2. Phase 3 Check-Mate -67T trial of subcutaneous nivolumab (nivolumab and hyaluranisade) meets co-primary end points in advanced or metastatic clear cell renal cell carcinoma. News release. Bristol Myers Squibb. October 19, 2024. Accessed May 6, 2024. 

3. A study of subcutaneous nivolumab versus intravenous nivolumab in participants with previously treated clear cell renal cell carcinoma that is advanced or has spread (CheckMate-67T). ClinicalTrials.gov. Updated October 12, 2023. Accessed May 6, 2024. 

https://www.clinicaltrials.gov/study/NCT04810078

The FDA is considering a subcutaneous nivolumab formulation for various solid tumors based on promising data from the phase 3 CheckMate -67T trial. A target action date has been set for December 29, 2024.

Clinical

FDA Accepts BLA for Subcutaneous Nivolumab Across Various Solid Tumors

As the 2025 American Society of Clinical Oncology Gastrointestinal Cancers (ASCO GI) Symposium approaches, community oncologists can expect a wealth of new data that may shape the future of GI cancer treatment.

“There is a lot of investigation going on, not only related to the development of new compounds, targeting different pathways…but also in the identification of patients who benefit more or less from available therapies,” explained Bruno Sangro MD, PhD, head of Hepatology Unit, Internal Medicine Department, Clinica Universidad de Navarra, in an interview with Targeted Oncology

Here are several of the most anticipated abstracts to keep an eye on:

 (NCT05141721), experts are exploring individualized neoantigen-targeting immunotherapy in metastatic microsatellite-stable colorectal cancer (CRC) (MSS-CRC).

 Early results show that GRANITE, a personalized neoantigen vaccine, improved progression-free survival (PFS) and long-term circulating tumor DNA (ctDNA) response compared with standard fluoropyrimidine and bevacizumab (Avastin).

Key phase 2 end points include molecular response (ctDNA decrease ≥ 30%), while phase 3 will focus on PFS. This study highlights the potential of personalized vaccines to transform MSS-CRC treatment.

: Findings from CALGB/Alliance SWOG 80702 (NCT01150045), a randomized, phase 3 trial, will be presented and are expected to further underscore the prognostic and predictive role of ctDNA in stage III colon cancer treated with celecoxib (Celebrex).

 The goal of the study is to compare how well oxaliplatin, leucovorin, and fluorouracil (FOLFOX) work together when given with or without celecoxib for the treatment of patients with stage III colon cancer previously treated with surgery.

Prior findings from the study have shown that the addition of celecoxib for 3 years to standard adjuvant chemotherapy did not significantly improve disease-free survival vs placebo.

: A phase 3 trial is investigating the role of low-dose aspirin in reducing recurrence rates among patients with CRC harboring 

 pathway alterations. These 3-year results may clarify the role of aspirin as an adjunct therapy for specific patient subgroups.

: The CheckMate 8HW (NCT04008030) trial is comparing nivolumab plus ipilimumab (Yervoy) with nivolumab monotherapy in MSI-H/dMMR metastatic CRC.

 At last year’s ASCO GI meeting, this combination given as a first-line treatment led to statistically significant and clinically meaningful improvements in PFS vs investigator’s choice of chemotherapy among patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer, meeting a dual primary end point of the study.

“There was the first readout of the combination immunotherapy from the 

 study that was looking at nivolumab/ipilimumab, which is a combination immunotherapy, anti–CTLA-4 with anti–PD-1, vs chemotherapy. They also had an arm of immunotherapy that we do not have enough data on yet, but the hazard ratio in terms of the proportion of people who were cancer-free was striking at 72% vs 14% or so for chemotherapy. The hazard ratio was [around] 0.21, so almost a 79% reduction in the risk. It is a huge benefit, and you could see the plateauing of immunotherapy,” explained Pashtoon Kasi, MD, MS, medical director at City of Hope, in an interview with 

“Immunotherapy in the MSI-high subset of patients continues to amaze us, and it is holding true with these combination therapies even more,” he continued.

With encouraging results, this combination may offer an enhanced approach for immunotherapy-sensitive CRC populations.

: KEYFORM-007 is a phase 3 study (NCT05064059) assessing the co-formulation of the anti–LAG-3 antibody favezelimab and pembrolizumab (Keytruda) in previously treated PD-L1–positive metastatic CRC. 

 showed that this combination did not extend survival compared with standard care.

 However, the findings add to the understanding of checkpoint inhibitor efficacy in this setting.

The fixed-dose combination of favezelimab and pembrolizumab is also being investigated in the KEYFORM-008 study (NCT05508867) for the treatment of patients with PD–(L)1-refractory classical Hodgkin lymphoma.

: The EORTC-1203 GITC INNOVATION trial (NCT02205047) is evaluating the integration of trastuzumab (Herceptin), with or without pertuzumab (Perjeta), into perioperative chemotherapy for patients with HER2-positive stomach cancer.

 According to first results from the trial presented at the 2023 ASCO Annual Meeting, the primary end point analysis did not meet the pre-specified criteria of efficacy for this combination. However, perioperative chemotherapy with trastuzumab led to promising response rates, emphasizing the need for follow-up data.

“[INNOVATION] is a global, phase 2 trial in HER2-positive gastric cancer. This has 3 arms comparing perioperative chemotherapy, whatever standard of care it is in the country, plus trastuzumab or adding trastuzumab with pertuzumab. I think it failed to meet the end point of a 20% better path response rate, but there was a better path response rate,” explained 

 surgical oncologist in the Division of Surgical Oncology, associate professor in the Department of Surgery, vice chair of international affairs, director of the Gastroenterology and Minimally Invasive Therapies Program at City of Hope, in a previous interview with 

Now, the overall survival (OS) results could cement the role of HER2-targeted therapies in perioperative settings.

: The ASPEN-06 phase 2/3 study (NCT05002127) of evorpacept (ALX148), a CD47 myeloid checkpoint inhibitor, is examining outcomes in HER2-overexpressing gastric or gastroesophageal junction (GEJ) cancer. According to

 clinically meaningful improvements in overall response rate (ORR) and duration of response were observed in patients with previously treated HER2-positive advanced gastric or GEJ cancer.

Final analysis of the phase 2 portion may reveal whether targeting CD47 improves responses to HER2-directed therapies.

: Five-year follow-up data from CheckMate 649 (NCT02872116) will be presented at the meeting, looking to confirm the long-term benefits of nivolumab plus chemotherapy as first-line treatment for advanced gastric, GEJ, and esophageal adenocarcinomas.

Nivolumab plus chemotherapy was approved by the FDA on April 16, 2021, for the first-line treatment of gastric/GEJ cancer without restriction by PD-L1 expression, based on 

. Here, the combination led to statistically significant and clinically meaningful improvements in PFS and OS compared with chemotherapy and placebo. In patients with a combined positive score (CPS) of greater than 5, the PFS HR was 0.68 (95% CI, 0.56-0.81) and the OS HR was 0.71 (98.4% CI, 0.59-0.86). In patients with a CPS of 1 or greater, the OS HR was 0.77 (99.3% CI, 0.64-0.92). In all randomized patients, the OS HR was 0.80 (99.3% CI, 0.68-0.94).

“We saw unequivocal improvements in overall survival for the patients with PD-L1 CPS 5 or higher with a nearly 3-month improvement in OS and with an HR of 0.7, which was highly statistically significant [95% CI, 0.61-0.71]. We also saw a significant improvement in PFS of about 2 months [HR, 0.71; 95% CI, 0.61-0.82],” explained 

, during a Case-Based Roundtable® event.

 “It’s key to note the tail on the [Kaplan-Meier] curve here showing that patients get sustained benefit from this treatment sometimes beyond 2 years of therapy, which is unprecedented.”

: The phase 3 SCIENCE trial (NCT05244798) is evaluating chemotherapy plus sintilimab (Tyvyt) and chemoradiotherapy plus sintilimab vs chemoradiotherapy alone as neoadjuvant treatments for patients with resectable locally advanced esophageal squamous cell carcinoma (ESCC).

 The multicenter, randomized study aims to determine if sintilimab can enhance treatment efficacy and provide a new standard for this patient population. Preliminary results will be presented at the meeting.

: In the LAPIS trial (NCT03941093), experts are evaluating chemotherapy with or without pamrevlumab (FG-3019) for locally advanced pancreatic cancer (LAPC) treatment. Recent data suggest pamrevlumab failed to meet survival end points in advanced settings.

LAPIS is a phase 3 study comparing gemcitabine and nab-paclitaxel or oxaliplatin, folinic acid, irinotecan, and fluorouracil (FOLFIRINOX) with and without pamrevlumab. The median OS was 17.3 months in the pamrevlumab arm vs 17.9 months in the comparator arm (HR, 1.08; 95% CI, 0.83-1.41; stratified log-rank 

The LAPIS study results to be presented at the ASCO GI meeting could help provide clarity regarding these primary end point findings.

Sintilimab plus NCT or NCRT versus NCRT for ESCC. Clinical Drug Experience Knowledgebase. Updated October 25, 2022. Accessed January 21, 2025. 

https://cdek.pharmacy.purdue.edu/trial/NCT05244798/

A study of a patient-specific neoantigen vaccine in combination with immune checkpoint blockade for patients with metastatic colorectal cancer. ClinicalTrials.gov. Updated December 22, 2023. Accessed January 21, 2025. 

Here are the most anticipated abstracts to keep an eye on going into the 2025 ASCO Gastrointestinal Cancers Symposium.

Barry Goy, MD

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