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Jennifer Marie Suga, MD, shares the lung cancer research she’s eager to explore as new data emerges.

Breakthroughs in Lung Cancer Research and Early Detection Strategies

Jennifer Marie Suga, MD, discusses how the results from next-generation sequencing tests are assessed to help physicians manage their patients in real-time.

Committee Helps Physician's Find Best Options for Patients Through NGS

Jennifer Marie Suga, MD, discusses implementing a genomic oncology program at Kaiser Permanente Northern California through large-scale genomic next generation sequencing testing of patients with advanced cancers in the community setting.

Discussing How to Bring Next-Generation Sequencing to Community Practices

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

Mirvetuximab soravtansine-gynx (Elahere) continues to demonstrate superior overall survival (OS) and sustained clinical benefits vs investigator’s choice of chemotherapy (ICC) in patients with folate receptor α (FRα)–positive, platinum-resistant ovarian cancer, according to the final analysis of the phase 3 MIRASOL trial (NCT04209855).

Presented at the 2025 Society of Gynecologic Oncology Annual Meeting on Women’s Cancer (SGO), the findings reinforce the role of this antibody-drug conjugate (ADC) as a transformative treatment option for patients with FRα–positive, platinum-resistant ovarian cancer.

The global, randomized, open-label study enrolled 453 patients with FRα-positive, high-grade serous ovarian cancer who had received 1 to 3 prior lines of therapy. At a median follow-up of 30.5 months, mirvetuximab (n = 227) achieved a median OS of 16.85 months (95% CI, 14.36-19.78) compared with 13.34 months (95% CI, 11.37-15.15) with ICC (n = 226), representing a 32% reduction in the risk of death (HR, 0.68; 95% CI, 0.54-0.84; 

 =.0004). Consistent OS benefits were observed across key subgroups, regardless of prior bevacizumab (Avastin) or PARP inhibitor use, number of prior therapies, or type of chemotherapy.

“Mirvetuximab should be the standard of care in high-grade serous ovarian cancer that expresses folate receptor alpha,” Toon Van Gorp, MD, PhD, told 

, emphasizing the significance of these results.

In the interview, Van Gorp of University Hospital Leuven Kefir Cancer Institute and BGOG, in Leuven, Belgium, discussed these findings and the potential of mirvetuximab to redefine treatment paradigms in ovarian cancer.

: Can you discuss the rationale behind the MIRASOL trial and what it sought to investigate?

 The MIRASOL study was a randomized trial, an open-label, phase 3 trial, which randomized patients between mirvetuximab soravtansine and investigator’s choice chemotherapy. In total, we randomized 453 patients, 1:1. The primary end point of the study was progression-free survival by the investigator. This was already published in the 

 and also presented at ASCO 2023. There were also secondary end points, hierarchical in order: objective response rate, overall survival, and patient-reported outcomes.

What were the key findings from this final analysis, and how do they reinforce the role of mirvetuximab in treating patients with ovarian cancer?

At the primary analysis, we had a follow-up time of 13.1 months. Back then, we had a positive result, of course, in favor of mirvetuximab for progression-free survival, overall survival, and objective response rate. Right now, we have a final analysis after a much longer follow-up, which was 30.5 months—one of the longest follow-up times we have ever seen in this setting, in the platinum-resistant setting, because usually, follow-up times are much shorter.

What we saw was that the results reinforced the protection of mirvetuximab. We had a positive result for overall survival: the median overall survival was 16.9 months for mirvetuximab, and it was 13.3 months for investigator’s choice chemotherapy. This gave a hazard ratio of 0.68, so a reduction of 32% in the risk of death due to the disease. The same was seen with progression-free survival, with a hazard ratio of 0.63—again, a very positive result. When we looked further into the results, including objective response rates, duration of response, and PFS2 (progression after the first recurrence), they were all in line, with positive results for all these end points. So, this is, of course, an excellent result for such a long follow-up in this very difficult-to-treat disease.

It is also very important to look at quality of life and health-related issues. There is another presentation during the SGO meeting about health-related quality of life related to treatment-emergent ocular adverse events. I think this is important because sometimes physicians are a little afraid of the ocular adverse events. I do not think it is necessary to be afraid of this—as long as you know how to handle it and have a good relationship with your ophthalmologist, who can help treat these adverse events. It is important that physicians know this is a well-tolerated drug.

What do these findings mean specifically for patients with platinum-resistant ovarian cancer?

I think this means that we have a better solution than investigator’s choice chemotherapy. I have to mention that this was, of course, a trial for folate receptor alpha–high ovarian cancer, so it’s not for all ovarian cancers—it is specifically for patients who have high folate receptor alpha expression. But for these patients, this definitely means that mirvetuximab is the standard of care because it is much better than standard chemotherapy, and this should be offered to patients as soon as they are confronted with platinum-resistant disease.

What were the long-term safety and tolerability profiles of mirvetuximab, and how does that compare with traditional chemotherapy options?

We had confirmation of the earlier results that we already saw. When we look at grade 3 or higher treatment-emergent adverse events or serious adverse events, we saw that they were less frequent with mirvetuximab. Also, adverse events that resulted in discontinuation of treatment were almost half the number compared with investigator’s choice chemotherapy. This means it is a tolerable treatment.

When we do a deep dive into specific treatment-emergent adverse events, we see less hematological adverse events compared to chemotherapy. There is some neuropathy, but it’s less than with paclitaxel and also less severe—usually grade 1 or 2. We do have some nausea and diarrhea, the same as with chemotherapy. The biggest difference, or something more specific to mirvetuximab, is the ocular toxicity, which is more common with mirvetuximab compared to chemotherapy. But again, this is mainly grade 1 or 2, and we have mitigation strategies with lubricating eye drops and steroid eye drops. If necessary, we do dose modifications when this happens.

What advice do you have for other oncologists who are treating patients using mirvetuximab?

My advice would be that one important aspect is we have to do the folate receptor alpha testing. That is really important. If we do not do it, we will never know whether a patient can receive mirvetuximab or not. Whether you do it at the time of diagnosis or when the patient becomes progressive or platinum-resistant does not matter, as long as we do it. The second thing is, when we have to decide what treatment to give a patient with platinum-resistant disease, I think there should be only one option, and that is mirvetuximab, because it is the best option both for efficacy and safety.

What are the next steps in the research or development of mirvetuximab? Are there plans to explore its use in other settings or combinations?

We know mirvetuximab is better than chemotherapy in platinum-resistant disease, but this is a powerful drug, so I think we should use it in earlier lines. There are ongoing studies in platinum-sensitive disease, looking at combining it with other treatments or giving it as maintenance. I am looking forward to these results because I think this drug should move to earlier lines so more patients can benefit from it.

Well, it is a difficult-to-treat disease. I think in the future, we’ll have to see what we can do with antibody-drug conjugates and whether we can expand treatments for these patients. I think if we can move our most powerful drugs to earlier lines, maybe we can save more patients. I would love to see this in first line, for example, but I do not know if that will happen. This drug has the potential to replace a drug like paclitaxel, but we don’t have that information yet, so we have to be careful. But I think we should invest more in earlier lines, before the disease becomes platinum-resistant, so we can save more patients.

In a few sentences, what are the key findings from this study?

The key findings are that at the final analysis, there was maintained efficacy for mirvetuximab over investigator’s choice chemotherapy for overall survival, progression-free survival, and objective response rates. Especially the overall survival—prolonging the life of patients with this difficult-to-treat disease is magnificent. There were no new safety signals, so in my opinion, mirvetuximab should be the standard of care in high-grade serous ovarian cancer that expresses folate receptor alpha.

Van Gorp T, Angelergues A, Konecny G, et al. Final overall survival analysis among patients with FRα-positive, platinum-resistant ovarian cancer (PROC) treated with mirvetuximab soravtansine (MIRV) vs investigator’s choice chemotherapy (ICC) in the phase 3 MIRASOL (GOG 3045/ENGOT-ov55) study. Presented at: 2025 SGO Annual Meeting on Women’s Cancer; March 14-17, 2025; Seattle, WA. Abstract 939696.

Toon Van Gorp, MD, PhD, discussed findings from the MIRASOL trial and the potential of mirvetuximab to redefine treatment paradigms in ovarian cancer.

Conference News

Mirvetuximab Shows Lasting Survival Benefit in Resistant Ovarian Cancer

KEY TAKEAWAYS FROM ADITYA BARDIA, MD, MPH​, FASCO

Trastuzumab deruxtecan and sacituzumab govitecan can be given to patients with metastatic HER2-low breast cancer after endocrine therapy and chemotherapy.

Progression-free survival and overall survival favor trastuzumab deruxtecan over chemotherapy in HER2-low disease.

The DESTINY-Breast06 trial showed similar outcomes for HER2-low and HER2-ultralow disease.

A 52-year-old postmenopausal woman underwent breast-conserving surgery plus radiation therapy for pT2 N1 invasive ductal carcinoma of the right breast, grade 2, estrogen receptor (ER)–positive, progesterone receptor–positive, HER2 1+ by immunohistochemistry (IHC); 21-gene recurrence score: 27​.

She received dose-dense doxorubicin and cyclophosphamide followed by paclitaxel and completed 10 years of tamoxifen.​

Five years later, she presented with disease recurrence in the liver, hormone receptor–positive, HER2-low, no actionable mutations on tissue next-generation sequencing​.

She received first-line letrozole plus ribociclib​ (Kisqali).

​She went on to receive ​fulvestrant for 6 months to disease progression in the bone and liver, then everolimus plus exemestane for 4 months to disease progression, followed by capecitabine for 6 months until disease progression.

During a Case-Based Roundtable® event, Aditya Bardia, MD, MS, FASCO, discussed data from the DESTINY-Breast04 and DESTINY-Breast06 trials for HER2-low breast cancer in the second article of a 2-part series.

Jennifer Marie Suga, MD

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