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BTK Inhibitors: In-Focus

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Oleg Gligich, MD, is an assistant professor at the Columbia University Division of Hematology/Oncology at Mount Sinai Medical Center.

Oleg Gligich, MD, discusses utilizing circulating tumor DNA to assess patients with lung cancer.

Timing of MRD Testing in Lung Cancer Affects Patient Outcomes

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.

News

Clinical

FDA Accepts BLA for Subcutaneous Nivolumab Across Various Solid Tumors

Future Treatment Landscape for EGFR-mutated Non-Small Cell Lung Cancer

Video content above is prompted by the following:

What do you see as the future treatment landscape for 

-mutant advanced non–small cell lung cancer (NSCLC)?

What are the current unmet needs in the treatment of 

What clinical pearls could you share with community oncologists in the treatment of 

Panelist discusses how the future treatment landscape for EGFR-mutant advanced non–small cell lung cancer is evolving to address current unmet needs and offers clinical pearls to community oncologists for optimizing patient care in this rapidly changing field.

Video Series

Revumenib Crosses the Finish Line For KMT2A-Rearranged Acute Leukemia

Revumenib (SNDX-5613) has received FDA approval for the treatment of adult and pediatric patients with relapsed/refractory (R/R) 

-rearranged acute leukemia. This approval is based on data from the phase 1/2 AUGMENT-101 trial (NCT04065399), which evaluated the efficacy and safety of the drug in a total of 94 patients with R/R 

 acute leukemia, acute lymphoblastic leukemia (ALL)/mixed phenotype acute leukemia, and acute myeloid leukemia (AML). Minimal residual disease was also evaluated in 10 patients as part of the study.

-rearrangements occur in patients with acute myeloid and ALL, in adults, children, and overall, and have a poor prognosis. Revumenib gives hope to those with relapsed and refractory 

disease. I hope to see this agent investigated in clinical trials for newly diagnosed 

AML and ALL,” Eytan M. Stein, MD, chief of the leukemia service and director of the Program for Drug Development in Leukemia, Division of Hematologic Malignancies, at Memorial Sloan Kettering Cancer Center in New York, New York, told Targeted Oncology

Dato-DXd Moves Into Last Phase For FDA Approval in EGFR-Mutated NSCLC

A newly submitted biologics license application seeks accelerated approval of datopotamab deruxtecan (Dato-DXd) for the treatment of metastatic or locally advanced 

-mutated non–small cell lung cancer (NSCLC). This indication replaced the initial nonsquamous NSCLC application following feedback from the FDA. The submission is based on data from the following trials/phases evaluating Dato-DXd in various designs: the phase 2 and phase 3 TROPION-Lung01 (NCT04656652), TROPION-Lung05 (NCT04484142), and TROPION-PanTumor01 (NCT03401385).

“TROPION-Lung01 was designed to test the potential to improve upon standard-of-care chemotherapy in patients with a broad, previously treated, advanced lung cancer patient population. The results, together with data from TROPION-Lung05, showed an especially pronounced benefit for patients with an 

 mutation, which informed our discussions with the FDA and the decision to seek accelerated approval of datopotamab deruxtecan in this patient population. TROPION-Lung01 has also provided exciting exploratory data supporting our biomarker development, which will be validated in ongoing and planned phase 3 lung cancer trials,” Susan Galbraith, executive vice president of Oncology Research and Development at AstraZeneca, stated in the press release.

“Managing CML Is a Marathon”: Gain Insights on

Maintaining open and personalized communication with patients treated for chronic myeloid leukemia (CML) is a necessity due to the growing arsenal of (TKIs) and the time spent on treatment. Certain patients achieve an early response, but for others, treatment can be lifelong, requiring prompt management of serious adverse events, Michael Mauro, MD, explained. Mauro explores the current challenges and real-world data on CML, highlighting new TKIs that have a significant effect.

“Managing CML is a marathon requiring a minimum of 3 to 5 years of therapy even with our current best thoughts on the curative pathway, and that is only for a select group of patients. This group of patients is able to achieve an early and optimum response. [However], for the majority of patients, it is chronic or even lifelong therapy—more like an ultramarathon. Managing adherence, compliance, [and] tolerability and keeping the lines of communication open with patients is essential, as adverse events are often lower grade, though serious ones must be managed quickly,” Mauro, director of the CML program in the leukemia service at Memorial Sloan Kettering Cancer Center in New York, New York, stated in an interview with Targeted Oncology

Key Updates in TKI Therapy Reveal A Notable Challenge in CLL

A challenge in managing chronic lymphocytic leukemia (CLL) is disease progression for patients who have been treated with covalent Bruton's tyrosine kinase (BTK) inhibitors and venetoclax (Venclexta), according to Nicole Lamanna, MD. At the 42nd Annual Chemotherapy Symposium Foundation, hosted by Physicians' Education Resource, LLC, Lamanna reviewed a range of treatment options for heavily pre-treated CLL, discussing pertinent trials as well as research on the potential role of chimeric antigen receptor (CAR) T-cell therapy in CLL.

“Our patients who have relapsed multiple times are becoming a new clinically unmet need. With the covalent and the venetoclax- based therapies, patients can be bridged to a non-covalent, like ibrutinib [Imbruvica]. These patients are not going to last that long, so they need to get on a clinical trial or bridge or receive CAR T-cell therapy if they’re eligible,” Lamanna said. Lamanna is an associate clinical professor of medicine in the Hematologic Malignancies Section of the Hematology/Oncology Division at Columbia University Herbert Irving Comprehensive Cancer Center in New York, New York.

Discussing Quadruplet Therapy in Transplant-Eligible Multiple Myeloma

Marc J. Braunstein, MD, PhD, FACP, and hematology/oncology fellow and Olivia Main, MD, discussed a case involving a patient with transplant-eligible multiple myeloma. In the discussion, they highlight data from the phase 2 GRIFFIN (NCT02874742) and PERSEUS (NCT03710603) trials, explaining the efficacy of a quadruplet regimen vs a triplet regimen for this patient population.

“Those who received the quadruplet regimen had statistically significant improvement…This was also seen both at the end of the induction therapy as well as at the end of final analysis. [The percentage of] those who achieved a CR or better after the end of induction was around 19% in the D-RVd group, but we saw this even further depth of response increase at the end of the final analysis to 83% in those who received the quadruplet regimen, compared with 60% of patients who received the triplet regimen alone. This led to another study, the PERSEUS trial, which also demonstrated that the quadruplet regimen improved the depth of responses for these patients,” Main explained in the discussion with 

Thank you for joining us for this week’s 

In case you missed it, here is last week’s 

The FDA grants approval to revumenib (SNDX-5613) for a subgroup of acute leukemia, and dato-dXd moves into the final stage in NSCLC. We also cover expert updates from the 42nd Annual Chemotherapy Symposium Foundation in CLL, as well as other relevant insights on CML and multiple myeloma treatment.

The Targeted Pulse: Discover Key FDA Actions in Leukemia and NSCLC and The Significant Effects of TKIs in CML and CLL 

Overview of Phase 3 EMERALD Study of Elacestrant for ER+, HER2–- MBC

Please give a brief overview of the phase 3 EMERALD study

Along with the Oncology Brothers, Paolo Tarantino, MD, provides an overview of the pPhase 3 EMERALD study, which evaluates the efficacy of elacestrant as a second-line treatment for ER+/HER2–- metastatic breast cancer, particularly in patients with ESR1 mutations.

He presented to his primary care physician (PCP) with symptoms of fatigue, night sweats, and increased bruising​.

His medical history includes type 2 diabetes, hypercholesterolemia, and hypertension.

“Normal” physical and blood work 1 year ago​

His PCP noticed lower hemoglobin (11-9.5 g/dL) and platelet count (350,000/μL-195,000/μL)​ from the previous year’s physical.​

He was referred to hematology/oncology; first available appointment in 2 months

At the appointment, exam findings include spleen 5 cm below left costal margin, worsening fatigue and night sweats, and bone pain.

He has a history of squamous cell carcinoma of the skin.

Blood: 1% blasts by manual count/flow cytometry

White blood cells: 19 × 109/L; hemoglobin: 9.1 g/dL; platelets: 135,000/μL; lactate dehydrogenase: 330 U/L

Bone marrow biopsy showed blasts less than 5% and grade 2/3 fibrosis

Karyotype was 46,XY [20], and next-generation sequencing panel showed a 

 V617F mutation with variable allele frequency of 53%

What patient symptoms prompt you to initiate therapy for MF? ​

What symptoms are the most important to control? ​

When do you start JAK inhibitor therapy?​

Do you choose your initial JAK inhibitor based on patient symptoms? ​

I'm curious to hear how you approach this in your practices, because it's probably a little bit different than what we that what we see here at University of Michigan in the academic setting. We tend to see patients a bit later.

In your practice, what patient's symptoms or findings would prompt you to initiate therapy for a patient with like this with a new diagnosis of myelofibrosis?

: Probably constitutional symptoms [such as] fever and night sweats, and splenomegaly. That usually tells me that I have to do something. That is what usually pushes me to start treatment if the patient is otherwise stable with stable [blood cell] counts.

The JAK inhibitors shrink the spleen…I only consider JAK inhibitors for patients with significant splenomegaly.

What do you think that JAK inhibitors leave to be desired?

To me, the reversal of bone marrow fibrosis is critical in managing myelofibrosis. So far, besides interferon, we don't have any drug that reverses or halts bone marrow fibrosis.

: If the principal issue is anemia, then one could consider [erythropoietin-stimulating agents or] luspatercept [Reblozyl] because the JAK2 inhibitors don't raise the hemoglobin [level] very well. But if the principal problem is splenomegaly or constitutional symptoms, then they're a good candidate for the JAK2 inhibitors.

That's a very good point. We assumed that when you shrink the spleen…the hemoglobin will go up. But JAK inhibitors also cause anemia.

During a Case-Based Roundtable® event, Kristen Pettit, MD, moderated a discussion on which disease features of myelofibrosis are most challenging and when to use JAK inhibitors in the first article of a 2-part series.

Oleg Gligich, MD

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