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David Gandara, MD, professor, Division of Hematology/Oncology, University of California Davis Comprehensive Cancer Center, discusses overcoming KRAS mutations in lung cancer. 

Strategies for Overcoming <em>KRAS</em> Mutations in Lung 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 demand for cancer care continues to rise, the US is facing a growing shortage of oncologists. Julie Gralow, MD, chief medical officer at the American Society of Clinical Oncology (ASCO), recently shed light on the factors contributing to this crisis and what can be done to address it. Gralow discussed the challenges of burnout, the impact of administrative burdens, and the need for systemic changes to support oncologists and improve patient care during an interview with 

One of the primary drivers of the oncologist shortage, according to Gralow, is the aging population.

“As more people live longer, the number of cancer cases is increasing, placing greater demand on oncology services. At the same time, the physician workforce is shrinking,” Gralow said. Many oncologists are leaving clinical practice earlier than expected, a trend exacerbated by burnout and the stresses of the COVID-19 pandemic, according to a survey by Schenkel and colleagues.

 A total of 5892 US-based oncologists were surveyed to determine their career intentions.

 Findings were compared with results from a 2013 survey of 1345 oncologists conducted by Shanafelt et al.

“Before the pandemic, we were already seeing a trend of physicians retiring early or reducing their clinical practice,” Gralow explained. “But the pandemic accelerated that. It’s clear that this is a stressful time, and we need to help keep people who want to keep working and seeing patients fulfilled in their jobs.”

Gralow highlighted alarming data on professional well-being and satisfaction among oncologists.

 Compared with the Shanafelt et al survey conducted in 2013,

 the results from this latest survey revealed a significant increase in burnout. In 2013, 34% of oncologists reported symptoms of burnout; by 2023, that number had risen to 59%. Emotional exhaustion and depersonalization—feeling callous toward patients—also saw sharp increases over the decade.

“Oncologists are reporting higher fatigue, lower quality of life, and less satisfaction with work-life integration,” Gralow said. “The top factor contributing to joy in their work is the patient relationship, but with the increasing administrative burden, time spent with patients is shrinking.”

The survey also identified key stressors contributing to burnout, including staffing shortages, the use of electronic medical records, and payer policies. Oncologists are spending more time on paperwork and less time with patients, leading to frustration and dissatisfaction.

“Enhanced practice and administrative support, as well as better patient care staffing, were cited as top factors that could improve oncologists’ work,” Gralow said. “We need to reduce unnecessary work and streamline processes to allow oncologists to focus on what they do best—caring for patients.”

ASCO is actively working to address these challenges. Gralow said the organization is advocating policy changes, such as expanding telemedicine flexibilities and reducing prior authorization requirements, which have been a significant source of frustration for clinicians.

A recent compilation report provided the state of professional well-being among oncologists, burnout trends among oncology fellows in training, strategies to improve professional wellness, a policy brief describing past efforts to improve oncology workforce well-being and opportunities for improvement.

Gralow also emphasized the importance of team-based care, where tasks are optimally distributed among medical assistants, nurses, and advanced practice providers to allow oncologists to work at the top of their scope of practice.

“We’re promoting team-based care and better task distribution,” Gralow said. “We need to ensure that everyone is working at the top of their scope of practice, but also that tasks aren’t being pushed up to the physician unnecessarily.”

The oncologist shortage is particularly acute in rural areas, where access to cancer care is limited. Gralow pointed to a pilot program in Montana as an example of innovative solutions. The Increasing Access to Cancer Care in Rural Montana, a pilot program that enlists Bozeman Health, Barrett Hospital & HealthCare, and Montana State University, is a hub-and-spoke model of cancer care launched in 2022.

The initiative established small clinics in remote areas, allowing patients to receive chemotherapy and consultations via telemedicine. This model aims to reduce the burden on rural patients who would otherwise have to travel long distances for care. “Rural communities are very underserved,” Gralow said. “We need more models like this to ensure that patients in these areas have access to quality cancer care.”

To address the long-term workforce shortage, efforts to attract more medical students and residents to the field of oncology are ongoing. ASCO offers free membership to students and trainees and supports oncology clubs at medical schools. Gralow emphasized the importance of mentorship and early exposure to the field.

“We need to show medical students that oncology is not just about cancer being depressing,” Gralow said. “It’s about building long-term relationships with patients and their families. Once they see that, they realize how rewarding it can be.”

ASCO is also focusing on promoting wellness and career fulfillment among oncologists. The organization has published recommendations for academic medical centers to support clinicians and reduce burnout. These include providing flexibility in daily schedules, reducing administrative burdens, and fostering a sense of community and connection among staff.

“Flexibility in daily schedules can make a big difference,” Gralow said. “Something as simple as allowing a clinician to adjust their hours to drop their child off at school can improve work-life balance.”

The oncologist workforce shortage is a complex issue that requires systemic changes at multiple levels. From reducing administrative burdens to promoting team-based care and expanding access in rural areas, there is much work to be done. Urgent action is needed to support oncologists and ensure that patients continue to receive the high-quality care they deserve.

“We need to support those people who want to keep working and seeing patients fulfilled in their jobs. That’s how we’ll address this crisis,” Gralow concluded.

1. Schenkel C, Levit LA, Kirkwood K, et al. State of Professional Well-Being, Satisfaction, and Career Plans Among US Oncologists in 2023. 

. 2025;2(1):e2400010. doi:10.1200/OA.24.00010.

2. Shanafelt TD, Gradishar WJ, Kosty M, et al. Burnout and career satisfaction among US oncologists. 

. 2014;32(7):678-686. doi:10.1200/JCO.2013.51.8480

3. New reports assess oncology workforce well-being, propose solutions to address burnout. ASCO In Action. January 29, 2025. Accessed March 6, 2025. 

4. Unique pilot program to increase access to cancer care in rural Montana reaches milestone. Bozeman Health Foundation. Accessed March 6, 2025. 

Julie Gralow, MD, shed light on the factors contributing to the growing shortage of oncologists in the US and what can be done to address it. 

Aging Population, Burnout Continue to Drive Oncology Workforce Shortage

Earlier in 2025, the American Society of Clinical Oncology (ASCO) released its first updated guidelines for the treatment of patients with malignant pleural mesothelioma (MPM) since 2018.

 The updated guidelines emphasize a more nuanced approach to surgery, the integration of immunotherapy, the importance of genetic testing, and refined pathologic insights.

These new recommendations were informed by 110 peer-reviewed studies that were conducted between 2016 and 2024. Each update reflects significant advancements in the understanding and management of this aggressive, asbestos-related cancer.

“The ASCO Guideline Update is not advocating for a “reduced role of surgery.” We do need to be more selective about which patients are offered surgical cytoreduction. However, just because it is anatomically feasible to resect does not mean one should do so,” explained Hedy Lee Kindler, MD, professor of medicine, section of hematology/oncology, associate dean for clinical science research, human subjects, The University of Chicago, Biological Sciences Division, in an interview with 

“The challenge is to identify which patient might benefit from resection. This would include appropriately staged patients with early-stage epithelioid disease who are evaluated by a multidisciplinary team. Optimally, cytoreduction should be performed at experienced centers with a documented history of low morbidity and mortality,” she added.

Surgery has long been a cornerstone of MPM treatment, but the updated guidelines suggest a more limited role. The phase 3 MARS-2 trial (NCT02040272) performed in the United Kingdom showed that at a median follow-up of 22.4 months, patients treated with chemotherapy alone had a longer median overall survival of 24.8 months (interquartile range [IQR], 12.6-37.4) compared with those who underwent surgery followed by adjuvant chemotherapy at 19.3 months (IQR, 10.0-33.7). The difference in restricted mean survival time at 2 years was -1.9 months (95% CI, 3.4 to -0.3; 

 =.019). Additionally, chemotherapy was linked with better quality of life and lower costs in the study.

As a result of this study and other published data, ASCO now recommends surgery only for carefully selected patients with early-stage disease and the epithelioid subtype, which is associated with a better prognosis. Surgical cytoreduction should not be routinely offered to all patients based solely on anatomic resectability, and surgery should be performed exclusively at high-volume mesothelioma centers with extensive expertise.

Advances in Systemic Therapies With Immunotherapy

Some of the key updates in the guidelines pertain to systemic therapies, particularly immunotherapy. The combination of ipilimumab (Yervoy) and nivolumab (Opdivo), approved by the FDA in 2020, is now recommended as a first-line treatment for non-epithelioid MPM, based on data from the 

 In the study, a significant survival benefit was seen among treatment-naive patients with MPM.

Updated ASCO guidelines for pleural mesothelioma refine surgery use, recommend immunotherapy, genetic testing, and improve pathologic classification for personalized care.

David Gandara, MD

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