BRAIN CANCER

HER2 Breast Cancer

BREAST CANCER

Bladder Cancer

Prostate Cancer

Renal Cell Carcinoma

GENITOURINARY CANCERS

Liquid Biopsies

GENOMIC TESTING

Colorectal Cancer

GIST

Gastric Cancer

GI CANCERS

Cervical Cancer

Endometrial Cancer

Ovarian Cancer

GYNECOLOGIC CANCERS

HEAD & NECK CANCERS

Bone Marrow & Stem Cell Transplant

HEMATOLOGY

CAR T-Cell Therapy

IMMUNOTHERAPY

Chronic Lymphocytic Leukemia

Chronic Myeloid Leukemia

LEUKEMIAS

Biomarker-Driven Lung Cancer

EGFR+ Lung Cancer

MET-Targeted Therapy

Small Cell Lung Cancer

LUNG CANCER

DLBCL

Follicular Lymphoma

Mantle Cell Lymphoma

LYMPHOMAS

MPNs

MULTIPLE MYELOMA

NTRK GENE FUSIONS

SARCOMA

Melanoma

SKIN CANCERS

THYROID CANCERS

NEWS

Special Reports

All News

FDA Briefs

Oncology Icons

The Targeted Pulse

Voices from the Field

CONFERENCES

Conference Coverage

Conference Listing

Data Dialogue with the Oncology Brothers

MEDIA

All Videos

Case-Based Peer Perspectives

Evolving Paradigms in Oncology

Expert Perspective Virtual Tumor Board

Interviews

Investigator Perspectives

Medical World News

Personalized Medicine

Pivotal Practice Views with the Oncology Brothers

Podcasts

Speaking Out

PUBLICATIONS

All Publications

Evolving Paradigms

Peers & Perspectives in Oncology

Targeted Therapies in Oncology

CASE-BASED ROUNDTABLE

PARTNERS

RESOURCES

CME/CE

Clinical Trials

Events

Precision Medicine Perspectives

Press Releases

Treatment Resources

SUBSCRIBE

Targeted Oncology provides news, videos, and reviews on the rapidly evolving world of targeted therapies and immunotherapy for oncologists treating patients in a community setting.

About Us

Advertise

Contact Us

CureToday.com

CancerNetwork.com

OncLive.com

OncNursingNews.com

Do Not Sell My Information

Privacy

Terms & Conditions

Editorial Board

Targeted Oncology - Immunotherapy, Biomarkers, and Cancer Pathways

Facebook

Linkedin

YouTube

Instagram

Featured Clinical Focus

BTK Inhibitors: In-Focus

Bone Marrow & SCT

EGFR-Positive Lung Cancer

Lung Cancer

Multiple Myeloma

Thyroid Cancers

Clinical Focus

Brain Cancer

Breast Cancer

Gastrointestinal Cancer

Genitourinary Cancers

Gynecologic Cancers

Head & Neck Cancers

Hematology

Leukemias

Lymphomas

Sarcoma

Skin Cancers

Spotlight

1rem

Authors

Tadd Lazarus, MD, Chief Medical Officer, QIAGEN, discusses the importance of companion diagnostics.

The Importance of Companion Diagnostics

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

Targeted Pulse

“Chemotherapy/Pembrolizumab SC is Noninferior to SOC” in NSCLC

In the phase 3 3475A-D77 study (NCT05722015), subcutaneous (SC) pembrolizumab (Keytruda) compared with intravenous (IV) pembrolizumab plus chemotherapy demonstrated non-inferior efficacy in metastatic non–small cell lung cancer (NSCLC). In this video, Enriqueta Felip, MD, PhD, explains the trial data regarding the trial design.

“In patients with lung cancer, the combination of chemotherapy plus pembrolizumab IV is standard of care for those patients without genomic alterations, and this is a randomized trial including patients with untreated stage IV non–small cell lung cancer and no alterations,” Felip, section chief at the Vall d'Hebron University Hospital, head of the Vall d' Hebron Institute of Oncology’s thoracic tumors group, Universitat Autònoma de Barcelona, Spain, explains. Access the full video 

Discussion on Optimizing Outcomes for High-Risk CML Into Blast Phase

Although the management of chronic myeloid leukemia (CML) has advanced in recent years, challenges persist in optimizing outcomes, particularly for those who have high-risk CML and those progressing to blast phase. In this article, Akriti Jain, MD, provides insight into the gaps in standardized regimens in blast-phase and discusses the impact of non-

“A lot of patients, especially younger patients (where we see blast-phase CML), have been through multiple tyrosine kinase inhibitors [TKIs] used for CML treatment, and they have burned through some of these TKIs because they were not taking them consistently. This can lead to mutations in the ABL1 tyrosine kinase domain, causing resistance. Resistant disease then leads to progression,” Jain, Department of Hematology and Medical Oncology, Cleveland Clinic explained. Access the full discussion 

Insights on the CAR T-Cell Field Advancing into the Solid Tumor Realm

Robert L. Ferris, MD, PhD, shares exciting information on upcoming advancements in the field of oncology, highlighting key presentations from the recent American Society of Clinical Oncology Gastrointestinal Cancers Symposium and the European Hematology Association/ European Bone Marrow Transplant 7th Chimeric Antigen Receptor (CAR) T-Cell Meeting. Ferris discussed that CAR T-cell therapy is making headway in the treatment of solid tumors. In addition, Ferris noted that hepatocellular carcinoma and 

-mutated colorectal cancer may benefit from multikinase-targeted inhibitors.

“Given the 5 or more hematologic cancers with approved cell therapies, we can expect future novel cellular approaches and clinical trials with extended clinical end points rather than simply first-in-human or toxicity questions being resolved,” wrote Ferris, Lineberger Distinguished Professor, executive director, UNC Lineberger Comprehensive Cancer Center and chief of Oncology Services, UNC Health System, Chapel Hill, North Carolina. Check out the full overview 

Success With Subcutaneous Administration of Pembrolizumab in NSCLC

In addition to the above video by Felip on the randomized, open-label 3475A-D77 study, this article delves deeper into the noninferior pharmacokinetic success of SC pembrolizumab with chemotherapy vs IV pembrolizumab with chemotherapy in metastatic NSCLC. In the trial, as first line therapy, 377 patients with metastatic NSCLC were randomly assigned to receive SC pembrolizumab with berahyaluronidase alfa (MK-3475A; SC pembrolizumab) plus chemotherapy, or IV pembrolizumab and chemotherapy. The median injection time with the SC pembrolizumab combination was 2 minutes.

“[Pembrolizumab] has helped transform the treatment of certain cancers, and we continue to pursue innovations that build on this breakthrough medicine to give patients and those who treat them better experiences,” said Marjorie Green, MD, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “If approved, we are excited about the potential of subcutaneous pembrolizumab to become a new meaningful treatment option that may increase access and save time needed for administration compared with IV [pembrolizumab].” For more trial data, access the full article 

Insights on Full Approval of Pembrolizumab/Trastuzumab for HER2+ Gastric Cancer

In this video, Yelena Y. Janjigian, MD, offers further insight into data from the phase 3 KEYNOTE-811 trial (NCT03615326), which supported the recent approval of pembrolizumab plus trastuzumab (Herceptin) and chemotherapy for HER2-positive locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Janjigian also provides insight into how this approval may affect the community setting by preparing clinicians to incorporate this new treatment combination for their patients.

“Pembrolizumab in combination with trastuzumab and chemotherapy has been a practice-changing treatment for HER2-positive disease. In fact, even as far back as 2019, when we initially were accruing to the phase 3 study in the US, we had trouble randomizing patients to the non-pembrolizumab-containing arm because many…were aware of our initial phase 2 data that we published in 

, and they did not want to be randomized to the non-pembrolizumab-containing arm,” explains Janjigian, chief attending physician of the Gastrointestinal Medical Oncology Service, Memorial Sloan Kettering Cancer Center in New York, New York. Access the full video 

Thank you for joining us for this week’s 

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

Chemotherapy/Pembrolizumab SC shows noninferior to SOC in NSCLC, expert insights on advances with CAR T-cells, and a full approval for gastric cancer.

The Targeted Pulse: SC Pembrolizumab Combo Matches SOC in NSCLC and CAR T-cells Transform the Solid Tumor Space

A 65-year-old man presented with back pain for past 6 months and hematuria for 1 week.

Physical examination: palpable mass in epigastric and left hypochondriac region, firm and not tender

Laboratory results: hemoglobin, 11.4 g/dL; lactate dehydrogenase, 980 U/L; all others within normal limits

Chest x-ray: widened mediastinum with bilateral hilar enlargement

Ultrasound of abdomen/pelvis showed a left renal mass, 8 cm, with multiple enlarged para-aortic nodes

CT scan of chest, abdomen, and pelvis showed multiple mediastinal and hilar nodes, deposits in left lower lobe of lung, enlarged axillary nodes, and enhancing mass in left renal parenchyma with renal vein infiltration; lytic destruction of L4 and L5 vertebrae, left superior pubic ramus, and right ischium

Fine needle aspiration of renal mass and bone biopsy confirmed metastatic clear cell renal cell carcinoma (ccRCC).

There is not one right answer here, but let's say a decision was made to initiate IO [immunotherapy] plus TKI [tyrosine kinase inhibitor], whether it's for patient preference, your preference, because you were looking for a higher and quicker response rate, whatever that may be. If you chose to do IO/TKI, what first-line regimen are you most likely to choose for this patient? Is that axitinib [Inlyta] plus pembrolizumab [Keytruda], cabozantinib [Cabometyx] plus nivolumab [Opdivo], lenvatinib [Lenvima] plus pembrolizumab, or something else?

Nobody is choosing other, which I think is very appropriate, because there is no other approved IO/TKI regimen. There are others studied, but, but none approved. Since we're divided equally, can somebody tell me why they chose axitinib/pembrolizumab? There are no clearly right answers.

 I chose the one with axitinib because it's easier to use and discontinue when needed, because it's only a 3-day period in which, if they have to have procedures or [other treatments], you don't have to be off of it for a whole 2 weeks before and after. It makes it easier to utilize. That's the main reason I tend to gravitate to that regimen more than the others.

I chose cabozantinib/nivolumab. In patients who have bone metastases, there are data that support using cabozantinib as opposed to other [TKI].

 For somebody has sarcomatoid pathology, or papillary renal cell carcinoma, I would choose cabozantinib.

With bony disease, you like cabozantinib. Remember, cabozantinib in a combination, is a dose of 40 mg, not 60 mg, which is the way it's approved for single-agent use.

I chose lenvatinib primarily because in the CLEAR study [NCT02811861], the overall response rate was higher.

 I don't think that there is a right or wrong answer. I have used all 3 combinations. My experience with lenvatinib has been positive. I have seen patients who tolerate lenvatinib pretty well. It's easy to adjust the dose for adverse events. For this particular patient, I would use lenvatinib/pembrolizumab. But for older or frail patients, I usually go with axitinib/pembrolizumab for the reasons that were mentioned earlier.

When you do lenvatinib/pembrolizumab, what dose of lenvatinib do you start with?

I start with the full dose and then I adjust as needed.

I chose lenvatinib/pembrolizumab too, but I have not had success having patients stay on the full dose. I pretty much always start at 14 mg [of lenvatinib], and then I try to go down or up based on their tolerance. Most people cannot do 20 mg.

For this patient, I picked lenvatinib/pembrolizumab because of the clear cell histology, and I think it's pretty well tolerated. Also, when you involve the patient in the decision making, you can offer them the every-6-week infusion [of pembrolizumab], and that gets their attention more than monthly [nivolumab].

That's a good point. Are you using those every-6-weeks [dosing], or are you doing every 3 weeks? Or do you start out with every 3 weeks and then move to every 6 weeks?

During a live event, Daniel M. Geynisman, MD, and participants discussed their answers to a poll on which combination to use for a patient with advanced renal cell carcinoma. 

Tadd Lazarus, MD

Articles

Latest Updated Articles