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Clinical

Karen M. Winkfield, MD, PhD; Narjust Florez, MD, FASCO; Gilberto de Lima Lopes Junior, MD, MBA, FASCO; Coral Olazagasti, MD; Vonetta M. Williams, MD, PhD

 Fighting Disparities and Saving Lives: An Exploration of Challenges and Solutions in Cancer Care

Heather McArthur, MD, MPH; Komal Jhaveri, MD, FACP; Sara Tolaney, MD, MPH; Seth A. Wander, MD, PhD

Community Practice Connections™: Exploring Emerging Next-Generation Endocrine Therapies in ER+/HER2- Breast Cancer – Evaluating the Potential of Future of Treatment

In season 2, episode 6 of Targeted Talks, Alexander B. Olawaiye, MD, associate professor of Gynecologic Oncology at the University of Pittsburgh and Magee-Women’s Hospital of UPMC Hillman Cancer Center (UPMC), lead a discussion with Haider S. Mahdi, MD, associate professor, Department of Obstetrics, Gynecology & Reproductive Sciences University of Pittsburgh and Magee-Women’s Hospital of UPMC about the modern approaches to treating cervical and endometrial cancers.

For cervical cancer, clinicians currently are faced with deciding upon radical surgery or chemoradiation for patients up to stage 1b. The ultimate goal for these patients is to focus on 1 modality because research has shown that patients who received both surgery and chemoradiation have greater complications later on. Patients who recur or present with stage IVB disease are typically treated with systemic therapy, and with these therapies, outcomes depend on the individual disease characteristics. Data around the benefits of bevacizumab (Avastin) for this patient population show potential for its use in the future.

Endometrial cancer is often diagnosed in the early stages due to its symptomatic nature. Because of this, endometrial cancer has high rates of remission. The current challenge oncologists face with treating the disease is when patients are diagnosed in the advanced stages. This is especially true for those with recurrent disease as few treatment options are available for these patients.

To push the field forward, both Olawaiye and Mahdi stress the importance of women have gynecologic symptoms checked out and being screened for cervical and endometrial cancers. Further, the use of biomarkers to determine with patients may benefit from immunotherapy is important for the future of treating cervical and endometrial cancers.

In season 2, episode 6 of Targeted Talks, Alexander B. Olawaiye, MD leads a discussion with Haider S. Mahdi, MD, about the modern approaches to treating cervical and endometrial cancers.

Advancing the Treatment of Cervical and Endometrial Cancers

In season 1, episode 2 of Targeted Talks, community physician Sarah M. Temkin, MD, a gynecologic oncologist at the Anne Arundel Medical Center in Annapolis, Maryland, leads a discussion with Daphne B. Stewart, MD, a medical oncologist and associate clinical professor at the City of Hope Comprehensive Cancer Center, in Duarte, California, around targeted therapies in ovarian cancer, whether offered in the academic or community setting.

The discussion covers the traditional methods for the frontline treatment of patients with recurrent ovarian cancer and how such methods compare with previous strategies and more modern strategies. Temkin and Stewart also touch upon the role of upfront genomic testing to provide precision medicine approaches to patients with germline or somatic 

 mutations, as well as those with homologous recombination deficiency. Although access to testing has improved over the years, they say, there are still barriers to getting access to testing for both germline and somatic mutations. The understanding of the necessity of dual testing and the results for homologous recombination deficiency testing also needs to be expanded, Stewart suggests.

As a conclusion to the topic, the experts review clinical trial research on single agents used for the treatment of patients in this population, in addition to combination therapies, and the management of toxicities from these treatment options.

Sarah M. Temkin, MD leads discussion with Daphne B. Stewart, MD, around targeted therapies in ovarian cancer, whether offered in the academic or community setting.


Precision Medicine Guiding Ovarian Cancer Treatment

New findings reveal mirvetuximab soravtansine significantly improves outcomes in patients with recurrent platinum-sensitive ovarian cancer, regardless of HRD status.

Mirvetuximab Active in Platinum-Sensitive Ovarian Cancer Regardless of HRD Status

Atezolizumab Efficacy in Cervical Cancer Consistent Irrespective of PD-L1

The survival benefit with cadonilimab in cervical cancer in the overall phase 3 COMPASSION-16 study population was sustained across prespecified subgroups.

Subgroup Data Sustain Cadonilimab Survival Benefit in Cervical Cancer

The FDA granted fast track designation to PHST001 for the treatment of advanced ovarian cancer.

FDA Grants Fast Track Status to PHST001 in Ovarian Cancer

T-DXd to Be Explored in HER2-Expressing Advanced Endometrial Cancer

, Premal Thaker, MD, MS, gynecologic oncologist at Siteman Cancer Center, Washington University in St. Louis, discusses data from the 

 (NCT03393884) exploring IMMN-1 added to to neoadjuvant and adjuvant chemotherapy for the treatment of newly diagnosed epithelial ovarian cancer. 

Data showed that at a median follow-up of 24 months, patients in the intention-to-treat (ITT) population given IMNN-001 plus chemotherapy (n = 59) achieved a median PFS of 14.9 months (95% CI, 12.55-21.19) compared with 11.9 months (95% CI, 10.09-14.92) in patients treated with chemotherapy alone (n = 54; HR, 0.79; 95% CI, 0.51-1.23).

At 24 months of follow-up, the median OS was 40.5 months (95% CI, 28.09-not evaluable [NE]) in the IMNN-001 arm vs 29.4 months (95% CI, 24.94-45.60) in the chemotherapy arm (HR, 0.74; 95% CI, 0.42-1.30; 

 =.2963). With follow-up extended to 31 months, the median OS was 46.0 months (95% CI, 39.20-NE) and 33.0 months (95% CI, 27.14-NE), respectively (HR, 0.69; 95% CI, 0.40-1.19; 

According to Thaker, the efficacy truly stands on its own, marking significant progress in drug development. 

Additionally, a crucial aspect learned from these trials is how to better support patients in receiving their medications, says Thaker. For instance, with intraperitoneal administration, which can be challenging due to adverse effects like abdominal pain, clinicians now employ prophylactic pain control and anxiety medication. 

A notable positive with this immunotherapy is the absence of cytokine release syndromes or other severe adverse effects previously associated with agents like interleukin-12, which was abandoned due to its toxicity profile. This intraperitoneal therapy avoids such issues while broadly engaging both the adaptive and innate immune systems. 

Thaker says it's important to note that this treatment is impacting a much larger component of the immune system, involving not just T cells or NK cells, but also macrophages and other elements.

Thaker P, Richardson D, Hagemann A, et al. A phase I/II study of the safety and efficacy of intraperitoneal IMNN-001 in combination with neoadjuvant chemotherapy (NACT) of paclitaxel and carboplatin in patients newly diagnosed with advanced epithelial ovarian cancer (EOC): updated survival analysis from OVATION-2 trial. 

. 2025;43(suppl 16):5516. doi:10.1200/JCO.2025.43.16_suppl.5516

Videos

Premal Thaker, MD, MS, discusses important implications and takeaways of the phase 1/2 OVATION study of IMMN-1 in addition to chemotherapy for the treatment of newly diagnosed epithelial ovarian cancer. 

IMMN-001 Shows Efficacy in Ovarian Cancer: OVATION-2 Trial Update

, Linda Duska, MD, FASCO, MPH, University of Virginia Health, discusses the unmet needs in the cervical cancer space, as well as the rational that prompted the KEYNOTE-A18 study (NCT04221945) of pembrolizumab (Keytruda) in addition to chemoradiation for the treatment of locally advanced cervical cancer. 

Cervical cancer is a leading cause of cancer-related deaths among women worldwide. What makes this particularly tragic, according to Duska, is its preventability through HPV vaccination and screening. Globally, the unmet need lies in reaching areas where these preventive measures are not readily available, leading to widespread suffering from this disease.

In the United States, significant racial inequities exist regarding cervical cancer incidence and survivorship. Furthermore, social determinants of health play a crucial role, as cervical cancer disproportionately affects low-income women, those without health insurance, and rural women. For example, regions like Appalachia exhibit high rates of cervical cancer due to these socioeconomic factors. Addressing this global cancer and women's access to care problem requires robust public health interventions.

Specifically regarding locally advanced cervical cancer, despite advancements in chemoradiotherapy, "we still can't cure every woman with locally advanced cervical cancer," Duska says. Unfortunately, not every woman in the United States even receives optimal radiation therapy. 

The KEYNOTE-A18 study aimed to improve treatment for these patients by investigating whether adding immunotherapy to modern chemoradiation could enhance progression-free and overall survival. Essentially, the study explored if the best possible chemoradiation could be made even better with the addition of immunotherapy.

Cervical Cancer: A Preventable Global Health Crisis for Women

MIRASOL: OS Benefit for Mirvetuximab in Platinum-Resistant Ovarian Cancer 

Toon Van Gorp, MD, PhD, University Hospital Leuven Kefir Cancer Institute and BGOG, in Leuven, Belgium, discusses the rationale behind the phase 3 MIRASOL trial (NCT04209855) of mirvetuximab soravtansine-gynx (Elahere) vs investigator’s choice of chemotherapy (ICC) in patients with folate receptor α (FRα)–positive, platinum-resistant ovarian cancer, and the key findings from a recent final analysis that was presented at the 

2025 Society of Gynecologic Oncology Annual Meeting on Women’s Cancer (SGO)

“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,” explains Van Gorp.

The study’s primary end point was progression-free survival by the investigator, and secondary end points included objective response rate, overall survival, and patient-reported outcomes.

According to findings from the primary analysis and a follow-up time of 13.1 months, positive results in favor of mirvetuximab for progression-free survival, overall survival, and objective response rate were observed. Now, with longer follow-up, which was 30.5 months, treatment with mirvetuximab (n = 227) led to a median OS of 16.85 months (95% CI, 14.36-19.78) vs 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). OS benefits were consistent across key subgroups, regardless of prior bevacizumab (Avastin) or PARP inhibitor use, number of prior therapies, or type of chemotherapy.

“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,” says Van Gorp.

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, discusses the rationale behind and the findings from the phase 3 MIRASOL trial of mirvetuximab soravtansine in patients with folate receptor α–positive, platinum-resistant ovarian cancer.

News

Nab-Sirolimus Yields Long-Lasting Benefits Across PEComa Subgroups

Thomas J. Herzog, MD, Paul & Carolyn Flory professor, University of Cincinnati, deputy director, University of Cincinnati Cancer Center, Cincinnati, OH, discusses the efficacy data seen in a subgroup analysis of the phase 2 AMPECT study (NCT02494570) evaluating nab-Sirolimus (Fyarro; ABI-009) for patients with perivascular epithelioid sarcoma (PEComa).

In the study, an overall response rate (ORR) of 37.5% (95% CI, 15.2%-64.6%) was observed among 16 female patients with malignant PEComa in uterine, ovarian, pelvic, and retroperitoneal sites, regardless of 

mutation status. All of the observed responses were confirmed partial responses.

Additional findings showed that the disease control rate (DCR) in the subgroup was 62.5%, and 4 of 16 patients (25%) experienced stable disease for at least 12 weeks. The subgroup was made up of over half of the evaluable study population. Further, the ORR from this analysis was similar to the 38.7% ORR observed in the overall population evaluation.

 With the overall response rate being the primary end point, the end point was very similar in terms of outcome between the subgroup analysis of the retroperitoneal gynecologic tumors compared with the whole AMPECT trial. [There was a] 37.5% overall response rate with a disease control rate of 63%, and that compared very favorably to 38.7% in the overall AMPECT trial with a disease control rate of 71%.

 The other important thing to remember, and looking at the spider plot really shows that the best, is the median time to response was extremely fast, about 1.4 months, and the duration of response was a little over 36 months. It is important to remember these responses occur often rapidly, and they are quite durable.

1. Herzog T, Dockery L, Dickson M, et al. Response to treatment with nab-sirolimus in patients with perivascular epithelioid cell sarcoma (PEComa) of gynecologic or peritoneal origin: subgroup analysis from AMPECT. Presented at: Society of Gynecologic Oncology 2024 Annual Meeting on Women's Cancer, March 16-18, 2024. San Diego, CA.

Thomas J. Herzog, MD, discusses the efficacy data seen in a subgroup analysis of the phase 2 AMPECT study evaluating nab-Sirolimus for patients with perivascular epithelioid sarcoma.


Conference News

AMPECT Study Shows Promising Safety With Nab-Sirolimus in PEComa Subgroups

Thomas J. Herzog, MD, Paul & Carolyn Flory professor, University of Cincinnati, deputy director, University of Cincinnati Cancer Center, Cincinnati, OH, discusses the safety findings of nab-Sirolimus (Fyarro; ABI-009) in a subgroup analysis of the phase 2 AMPECT study (NCT02494570) looking at patients with perivascular epithelioid sarcoma (PEComa).

2024 Society of Gynecologic Oncology Annual Meeting

 and showed that 100% of patients experienced treatment-related adverse events (TRAEs) of any grade, while 63% of patients had a TRAE of grade 3. The most common any-grade TRAEs included stomatitis (81%), fatigue (63%), edema (56%), maculopapular rash (56%), diarrhea (50%), and nausea (50%).

For grade 3 TRAEs, stomatitis (25%), hyperglycemia (13%), hypokalemia (13%), increased amylase (6%), vomiting (6%), and diarrhea (6%) were observed. Additionally, there were no grade 4 or 5 TRAEs seen, TRAEs led to dose delay in 63% of patients, dose reduction in 31%, and treatment discontinuation in 6%.

So all the patients in the gynecologic retroperitoneal subgroup analysis, all 16 of them experienced some treatment-related adverse events. Most of them were grade 1 or 2 with the most frequent in that category or overall being stomatitis, fatigue, edema, rash, and anemia.

There were a number of patients that had grade 3 events, with almost two thirds experiencing that, and the most frequent there were stomatitis, anemia, dehydration, hyperglycemia, and hyperkalemia.

 The only thing that I would comment on is there were 4 patients that had interstitial lung disease or pneumonitis. Fortunately, in the subgroup only grade 1 and grade 2 was observed, and none of those patients had to come off treatment for this treatment-related adverse event.

Thomas J. Herzog, MD, discusses the safety findings of nab-Sirolimus in a subgroup analysis of the phase 2 AMPECT study looking at patients with perivascular epithelioid sarcoma.


Expert Guidance for Patients With PEComa and Sarcoma

Thomas J. Herzog, MD, Paul & Carolyn Flory professor, University of Cincinnati, deputy director, University of Cincinnati Cancer Center, Cincinnati, OH, discusses the importance of patients seeing a gynecologist oncologist or a sarcoma doctor for gynecologic perivascular epithelioid sarcoma (PEComas).

, Herzog presented on nab-Sirolimus (Fyarro; ABI-009), the first and only FDA-approved treatment for locally advanced or metastatic malignant unresectable PEComa, and findings from a subgroup analysis of the phase 2 AMPECT study (NCT02494570) in patients with PEComa. In the study, nab-Sirolimus led to rapid and durable responses in patients with PEComa.

For those diagnosed with a PEComa, Herzog explains that the choice of where to seek treatment depends on factors like location and resources. Ideally, it is recommended to visit a high-volume gynecologist or a facility with a dedicated sarcoma program. Additionally, he explains that confirming the pathology and consulting with a physician experienced in treating sarcomas is crucial for creating an effective treatment plan.

In terms of where to go if you have a PEComa, or even a sarcoma, I think it depends on obviously, where you live and what your resources are, and so forth. Ideally, you would go to a high volume gynecologist who treats a significant number of sarcomas. Or certainly if they have a sarcoma program, that is always a good choice as well.

The key upon diagnosis of a sarcoma or PEComa is to make sure that the pathology is confirmed, and that you are seeing a physician who has high volume in sarcoma. That may be your gynecologic oncologist, or it may be a sarcoma specialist. I think either of those are great places to start. I do think that getting that expert opinion, though, is really key in getting the best outcome and treatment plan.

Thomas J. Herzog, MD, discusses the importance of patients seeing a gynecologist oncologist or a sarcoma doctor for gynecologic perivascular epithelioid sarcomas.

GYNECOLOGIC CANCERS

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