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Authors

Uday R. Popat, MD, discusses the rationale behind evaluating itacitinib over other JAK inhibitors for graft-vs-host disease prophylaxis in a phase 2 study.


Choosing Itacitinib for GVHD Prophylaxis: Insights From Popat

Uday R. Popat, MD, discusses a phase 2 trial exploring the use of itacitinib combined with post-transplant cyclophosphamide and tacrolimus to prevent graft-vs-host disease in patients undergoing a myeloablative fractionated busulfan regimen. 


Preventing GVHD With Itacitinib in Stem Cell Transplants

Uday R. Popat, MD, discusses the role of ruxolitinib as treatment of patients with graft-versus-host-disease.

Ruxolitinib Appears Effective as Treatment of Steroid-Refractory GVHD

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

A 52-year-old postmenopausal woman with endocrine-refractory, metastatic (bone only), estrogen receptor–positive (85%), progesterone receptor–positive (65%), HER2 2+ immunohistochemistry/in situ hybridization (ISH)–negative breast cancer had progression 14 months after starting first-line fulvestrant plus ribociclib.

Initial response to fulvestrant plus ribociclib noted on imaging at 3 months.

New areas of bone involvement in T-spine, left ribs, and L2

Circulating tumor DNA showed no actionable alterations.

Trastuzumab deruxtecan (Enhertu; T-DXd) was initiated.

The patient experienced moderate diarrhea and fatigue, with 2 temporary holds for neutropenia.

Chest/abdomen/pelvis CT and bone scan: 2 liver lesions, 1.8 cm and 2.4 cm; persistent bony metastases consistent with progressive disease; lung lesions too small to characterize, but in setting of other findings concerning for metastatic disease

Targeted Oncology: What other options are there for this patient as second-line therapy?

 In the second line for hormone receptor–positive, HER2-[positive/ISH] negative disease, the NCCN does list if you haven't used T-DXd, which in this case we did; that's also category 1 preferred.

 If they can't get T-DXd or if they've already received it, then the guidelines list sacituzumab govitecan [Trodelvy] as category 1, as well as systemic chemotherapy and then datopotamab deruxtecan [Datroway]. There were no wrong answers.... [For this patient], because of the efficacy of sacituzumab and because you want to treat patients when they're more able to tolerate, [it makes sense].

Best response of partial response observed, with further symptomatic improvement

Patient maintained an absolute neutrophil count of 3,900/μL and white blood cell count of 7,800/μL.

Can you discuss the phase 3 data that led to the approval of sacituzumab for a patient with breast cancer such as this?

The TROPiCS-02 study [NCT03901339] looked at patients with hormone receptor–positive, HER2-negative breast cancer who progressed after at least 1 prior endocrine therapy, a CDK4/6 inhibitor, and a taxane.

 Patients had to have 2 to 4 lines of chemotherapy... for this pretreated population. Patients were randomly assigned to sacituzumab vs treatment of physician’s choice, which included eribulin, vinorelbine, capecitabine, or gemcitabine.... The primary end point was progression-free survival (PFS), and the usual secondary end points looking at tolerability and efficacy.

What was the efficacy seen in the TROPiCS-02 trial?

The study essentially showed a PFS benefit of sacituzumab that was maintained over time [HR, 0.65; 95% CI, 0.53-0.81; 

 At 6 months, 12 months, and 18 months, there's still been a PFS benefit compared with treatment of physician’s choice that seems relatively maintained. I think also notable is the delta consistently seen [over time]. The 12-month PFS rate was 21.7%.... The final analysis looking at overall survival [OS], we do see an OS benefit as well [HR, 0.79; 95% CI, 0.65-0.96; 

When we look at the subgroup analysis, this is important because... [we're seeing patients with varying levels of] HER2-negative, HER2-low, or HER2-ultralow disease. So, what we're seeing is the same benefit in the patients who have HER2-low breast cancer who received sacituzumab [as those with HER2-negative disease].

How did patients do in terms of toxicity with sacituzumab?

The safety profile of TROPiCS-02 essentially showed 74% of patient had grade 3 or higher treatment-emergent adverse events with sacituzumab and 60% [did] with treatment of physician's choice. There were 66% of patients with a dose delay compared with 44% patients, respectively. There is some toxicity, but there were no [new] safety signals that emerged with initial follow-up.

1. NCCN. Clinical Practice Guidelines in Oncology. Breast cancer; version 3.2025. Accessed March 31, 2025. 

https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf

2. Rugo HS, Bardia A, Marmé F, et al. Overall survival with sacituzumab govitecan in hormone receptor-positive and human epidermal growth factor receptor 2-negative metastatic breast cancer (TROPiCS-02): a randomised, open-label, multicentre, phase 3 trial. 

. 2023;402(10411):1423-1433. doi:10.1016/S0140-6736(23)01245-X

3. Tolaney SM, Bardia A, Marmé F, et al. Final overall survival (OS) analysis from the phase 3 TROPiCS-02 study of sacituzumab govitecan (SG) in patients (pts) with hormone receptor–positive/HER2-negative (HR+/HER2–) metastatic breast cancer (mBC). 

. 2023;41(suppl 16):1003. doi:10.1200/JCO.2023.41.16_suppl.1003

During a live event, Payal D. Shah, MD, discusses the case of a woman with metastatic breast cancer and the data for third-line sacituzumab govitecan.

Treating Metastatic Breast Cancer After Endocrine Therapy and T-DXd

A 52-year-old, postmenopausal woman had a history of grade 2, node-negative invasive ductal carcinoma (IDC).

Estrogen receptor positive (ER+) and progesterone receptor positive (PR+); HER2 immunohistochemistry (IHC) 0; Ki-67 20%​ of the right breast; 21-gene recurrence score, 27

Initial therapy included chemotherapy, radiation therapy, and 5 years of adjuvant anastrozole.

Three years after completing anastrozole​, metastatic progression was discovered, including symptomatic bone involvement (multiple vertebrae and bilateral iliac crests).

Bone marrow aspiration confirmed ER+/PR+, HER2 IHC 0, stage IV IDC.

The patient started letrozole and ribociclib (Kisqali) with denosumab (Xgeva), with good clinical response and marked improvement in her pain​.

Required 1 dose reduction to 400 mg ribociclib due to neutropenia.

Twenty months after starting therapy, routine staging scans showed new FDG-avid sclerotic and lytic bone lesions​.

She noted mild increase in lower back pain​.

Circulating tumor DNA (ctDNA) analysis confirmed an 

During a Case-Based Roundtable® event, Ruth M. O'Regan, MD, looks at options for a patients with hormone receptor–positive, HER2-negative breast cancer and an ESR1 mutation in the second article of a 2-part series.

Uday R. Popat, MD

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