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Lipika Goyal, MD, discusses first-line options for patients with patients with hepatocellular carcinoma.

Sequencing Therapies in the First and Second Line for Patients With HCC

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

Challenges Facing Clinicians and Community Oncology Practices

Community oncology practices across the country are grappling with a growing financial burden that threatens their ability to deliver consistent, high-quality care. As the landscape of cancer treatment evolves—with advanced medications, new technologies, and rising operational costs—smaller, independent practices are feeling the squeeze more than ever.

Nini Wu, MD, MBA, chief medical and development officer of Navista, a Cardinal Health company, addresses the escalating financial pressures in oncology care.

“When we think about the practices, community practices have to shoulder a significant amount of financial burden with purchasing the equipment, purchasing medications upfront because of reimbursement through buy and bill. And with that, they're often waiting for the investment—that impacts the cash flow and impacts the financial stability of the practices,” Wu explains.

With cancer projected to be among the most expensive medical conditions, Wu outlines the significant hurdles facing community oncology practices as they strive to manage these rising costs while upholding high-quality patient care. Her insights delve into the multifaceted challenges impacting clinicians, practices, and, critically, the patients and their care partners navigating this complex landscape.

She explains the financial model of "buy and bill," where practices must purchase medications upfront and wait for reimbursement, the uncertainty around healthcare policy, particularly regarding Medicare reimbursement, and inflation that has steadily eroded the value of reimbursement over the past decade.

“Analyses have shown that overall payment cuts may hit as high as 3 to 4 percent. And that is significant because, in the community, the practices are not always large, and they do not have the support that you may find in the academic side or in larger groups. So they are challenged having to deal with this,” says Wu.

“In addition, you know, inflation materially impacts that. When we look back over the past, one study showed that over the past 12 years or so, there has really been no fundamental change in the level of reimbursement from a community practice viewpoint,” she adds.

Diagnostic Challenges in Myelofibrosis: Distinguishing Prefibrotic Disease_

Challenges in Distinguishing Pre-Fibrotic Myelofibrosis from Other MPNs:

 presents several diagnostic challenges, particularly in differentiating it from other 

Philadelphia chromosome–negative myeloproliferative neoplasms (MPNs)

 often share similar presentations—such as 

—making them difficult to distinguish based on clinical features alone.

Splenomegaly and constitutional symptoms may be mild or absent in early stages of both conditions.

increased megakaryocyte proliferation and atypia

 without significant reticulin fibrosis (grade 0-1).

Distinguishing these subtle histologic features from ET—where megakaryocytes are more mature and clustered differently—can be subjective and requires experienced hematopathology interpretation.

Misclassification has important consequences, as 

 of progression to overt myelofibrosis or 

, treatment planning, and surveillance intensity.

), which do not definitively differentiate between the entities.

) may provide prognostic value but are not routinely used to distinguish between MPN subtypes.

Lack of Uniform Awareness or Criteria Application

 are applied across institutions may lead to inconsistent diagnoses.

Increased awareness and standardization in using the diagnostic criteria are needed to improve diagnostic accuracy.

 is complex due to overlapping features, subjective histologic interpretation, and limited discriminative value of molecular findings. A multidisciplinary approach involving experienced 

, and clinical correlation is essential for accurate diagnosis and appropriate management.

Panelists discuss how distinguishing pre-fibrotic myelofibrosis from other myeloproliferative neoplasms like essential thrombocythemia remains challenging due to overlapping clinical and molecular features, subjective histopathologic interpretation, and variable application of diagnostic criteria, underscoring the need for expert pathology review and multidisciplinary evaluation to guide accurate diagnosis and management.

Video Series

Diagnostic Challenges in Myelofibrosis: Distinguishing Prefibrotic Disease

The FDA granted clearance to the investigational new drug (IND) application of TGW101 for the treatment of patients with advanced solid tumors.

TGW101 is a first-in-class antibody-drug conjugate (ADC) that works to target tumor associated glycoprotein 72 (TAG-72) with a monomethyl auristatin E (MMAE) payload.

With this clearance, a phase 1 clinical trial plans to evaluate the agent in this patient population.

The FDA cleared the IND application of TGW101, allowing for a phase 1 clinical trial to study the agent in patients with advanced solid tumors.

TGW101 is being evaluated in an ongoing, open-label, multicenter, phase 1 dose-escalation study for the treatment of patients with advanced solid tumors. The primary end points of the trial are to assess safety, tolerability, and pharmacokinetics, and to establish the maximum tolerated dose, recommended phase 2 dose, and optimal dosing regimen for future study.

The trial is currently enrolling at select sites in the US and aims to recruit up to 50 patients.

"TAG-72 is a validated target with overexpression in many high unmet need solid tumors. However, due to its noninternalizing nature, this target has remained unreachable by current ADCs and other therapies which require uptake by tumor cells to activate their antitumor activity. TGW101's highly differentiated profile enables controlled MMAE payload release and activation in the tumor microenvironment without internalization by tumor cells. This controlled drug release is achieved through a click reaction of the ADC linker with a trigger molecule, which is administered in a second step," said Marc Robillard, chief scientific officer and cofounder of Tagworks, in a press release.

"TGW101 has demonstrated a favorable safety profile as well as effective and durable responses in preclinical solid tumor models. The IND clearance and initiation of our phase 1 clinical trial is a significant milestone for our lead program and Tagworks, the pioneer of Click-to-Release chemistry," Robillard continued.

TGW101 is a first-in-class ADC currently under investigation for the treatment of advanced solid tumors. The therapy targets TAG-72, a noninternalizing surface antigen expressed across a range of epithelial-derived malignancies.

TGW101 is composed of a TAG-72-binding diabody linked to the cytotoxic agent MMAE.

 Unlike traditional ADCs that rely on internalization and lysosomal degradation, TGW101 leverages a novel 2-step mechanism. First, TGW101 is administered via intravenous (IV) infusion and binds to TAG-72 on the surface of tumor cells. Following tumor binding, a small-molecule trigger is delivered IV. This agent selectively cleaves the chemical linker of tumor-bound TGW101, releasing the MMAE payload into the extracellular tumor microenvironment. Further, the MMAE diffuses into nearby tumor cells.

Phase 1 trial of TGW101 in advanced solid tumors is enrolling to assess safety and pharmacokinetics and define the maximum tolerated dose in up to 50 patients.

Lipika Goyal, MD

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