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Sacituzumab govitecan/pembrolizumab in the first line lengthened PFS vs chemotherapy/pembrolizumab in PD-L1+ metastatic triple-negative breast cancer.

Sacituzumab Govitecan/Pembrolizumab Backed as New SOC in PD-L1+ TNBC

T-DXd led to improvements in OS, PFS, ORR, and DOR compared with ramucirumab/paclitaxel in the second line for HER2-positive gastric and GEJ cancer.

T-DXd Earns Second-Line SOC for HER2+ Gastric/GEJ Cancer

Patients with ESR1-mutated, ER-positive, HER2-negative, advanced breast cancer experienced an increase in PFS with vepdegestrant compared with fulvestrant.

Vepdegestrant Increases PFS in ESR1-Mutated ER+/HER2- Breast Cancer

Encorafenib and cetuximab plus mFOLFOX6 increased progression-free survival for patients with metastatic colorectal cancer harboring BRAF V600E mutations.

Encorafenib/Cetuximab With mFOLFOX6 Lengthens PFS in BRAF V600E+ mCRC

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 in November 2021 as a senior editor and became the website's managing editor in October 2023. Before arriving at MJH Life Sciences, he spent nearly a decade covering professional and high school sports—including the New Jersey Devils and the NHL from 2016 to 2021—for The Star-Ledger and NJ.com. Email: chryan@onclive.com

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The novel antibody-drug conjugate EBC-129 has been fast tracked by the FDA for approval in pancreatic ductal adenocarcinoma.

Novel ADC Receives FDA Fast Track Designation for Pancreatic Cancer

Oncology Nursing News connects oncology nurses and APPs with updates on therapy advances, side effect management, and patient-centered cancer care.

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Randi Kihnel, MSN, APRN, ACCNS-AG is an advanced practice nurse who works in GI Medical Oncology at Ochsner MD Anderson Cancer Center.

The FDA has granted accelerated approval to telisotuzumab vedotin-tllv (Teliso-V; Emrelis) for use in adult patients with locally advanced and metastatic non-squamous, non-small cell lung cancer who have received prior systemic therapy and have high c-Met protein overexpression, according to a news release from AbbVie, the drug’s developer.

The approval is based on data from the phase 2 LUMINOSITY study (NCT03539536). Patients on the trial with high c-Met expression in NSCLC (n = 84) saw a 35% overall response rate (ORR; 95% CI, 24%-46%). The median duration of response (DOR) was 7.2 months (95% CI, 4.2-12).

The most common adverse events (AEs), present in at least 20% of patients, were peripheral neuropathy, fatigue, decreased appetite, and peripheral edema. The most frequent laboratory abnormalities of grade 3 or 4, reported in at least 2% of patients, were lymphocytopenia, hyperglycemia, increased alanine aminotransferase, increased gamma glutamyl transferase, hypophosphatemia, hyponatremia, decreased hemoglobin, and hypocalcemia.

“Despite the progress we have seen in the treatment of lung cancer, we need more options for people whose treatments stop working,” Upal Basu Roy, PhD, MPH, executive director of research of the LUNGevity Foundation, said in the release. “This approval is a welcomed targeted therapy for those with high c-Met protein overexpressing late-stage, non-small cell lung cancer who have seen very limited treatment innovation in the last decade.”

A Closer Look at Safety Data from LUMINOSITY

Prior data reported from LUMINOSITY reported an ORR of 34.6% (95% CI, 24.2%-46.2%) and a median DOR of 9.0 months (95% CI, 4.2-13.0) in patients with non-squamous 

-wildtype NSCLC with high c-Met overexpression.

Median overall survival (OS) and progression free survival (PFS) were 14.6 months (95% CI, 9.2-25.6) and 5.5 months (95% CI, 4.1-8.3), respectively, for those patients.

, reported that the most common treatment-related adverse events (TRAEs) of any grade were peripheral neuropathy (30%), peripheral edema (16%), and fatigue (16%). The most common AEs of grade 3 or higher was peripheral neuropathy (7%). At the primary analysis, the median time to onset of response was 1.41 months (range, 1.0-7.4).

In total, 68 patients with high c-Met overexpression experienced TRAEs (81.0%), and 25 experienced grade 3 or higher TRAEs (29.8%). Grade 5 AEs that may be related to treatment were reported in 2 patients (1.2%).

TRAEs led to treatment discontinuation in 21.5% of patients with non-squamous 

-wildtype NSCLC. The TRAEs that most often led to discontinuation were pneumonitis (7.6%), peripheral sensory neuropathy (7.0%), peripheral sensorimotor neuropathy (2.3%), and interstitial lung disease (ILD; 1.2%). The median time to onset of ILD and peripheral neuropathy resulting in treatment discontinuation were 48 days (range, 7-344) and 222.5 days (range, 57-519), respectively. One death was considered related to ILD, and 2 were considered related to disease progression.

“[Telisotuzumab vedotin-tllv], AbbVie’s first internally developed solid tumor medicine and our first solid tumor FDA approval in lung cancer, is a testament to our commitment to develop cancer therapies that aim to improve the course of treatment for patients facing this challenging disease,” stated Roopal Thakkar, MD, executive vice president of research and development and chief scientific officer at AbbVie in the announcement. “Leveraging advanced technology and data science, we are growing our ADC portfolio designed to deliver the right medicines to the right patients in need across a range of difficult-to-treat tumors.”

U.S. FDA approves EMRELIS™ (telisotuzumab vedotin-tllv) for adults with previously treated advanced non-small cell lung cancer (NSCLC) with high c-Met protein overexpression. News release. AbbVie. May 14, 2025. Accessed May 14, 2025. https://news.abbvie.com/2025-05-14-U-S-FDA-Approves-EMRELIS-TM-telisotuzumab-vedotin-tllv-for-Adults-With-Previously-Treated-Advanced-Non-Small-Cell-Lung-Cancer-NSCLC-With-High-c-Met-Protein-Overexpression

Camidge DR, Bar J, Horinouchi H, et al. Telisotuzumab vedotin monotherapy in patients with previously treated c-Met protein-overexpressing advanced nonsquamous EGFR-wildtype non-small cell lung cancer in the phase II LUMINOSITY trial. 

. 2024;42(25):3000-3011. doi:10.1200/JCO.24.00720

Telisotuzumab vedotin-tllv has earned accelerated approval for use in patients with non-squamous non-small cell lung cancer with high c-Met overexpression.

Telisotuzumab Vedotin-tllv Given Accelerated Approval for NSCLC

The second-line treatment of mutated hormone receptor (HR)-positive, HER2-negative metastatic breast cancer can become more complex when considering the potential of mutated cancer.

John Novak, PA-C, of the University of Colorado Medicine, led a 

 regarding how to address treatment for patients with HR-positive, HER2-negative metastatic breast cancer.

What was the focus of discussion at the forum?

The overall premise of the forum…was the evolving second-line treatment landscape, and hormone receptor-positive, HER2-negative, metastatic breast cancer. Basically, we focused on how to approach that patient who progresses on first-line endocrine therapy…. And something that's really important is, our people, our providers, doing molecular profiling or molecular testing to determine if the patient has a new or acquired mutation that we can potentially target. Two really important targets that are acquired when this type of breast cancer is exposed to endocrine therapy is 

 and the treatments are a little bit different.

The focus…No. 1, is testing being done?… And No. 2, if they have an 

 mutation, how would you treat that patient? And elacestrant (Orserdu) is an oral selective estrogen receptor degrader that…is indicated for patients who…develop an 

 mutation. Then kind of the second thought process was, “OK, if someone has a co-mutation, if a patient has a co-mutation, 

 mutation, which target would you focus on?”… Because the treatments are a little bit different. So the patient who has a 

 mutation, per se, would be treated with fulvestrant (Faslodex), which is an injectable SERD, plus alpelisib (Piqray), which is a drug that targets 

How do you decide whether to focus on targeting 

One of the big factors is tolerability, or the [adverse] effect profile. I think everyone was in agreement that elacestrant is a much better-tolerated medication or treatment overall compared to the PI3KCA inhibitor…. The other factor is that you know elacestrant is an oral drug that you take every day, whereas the other 2 regimens require a patient to come into the clinic every 4 weeks to get an injection in addition to the oral medication that targets 

What should providers know when making treatment decisions about HR-positive, HER2-negative breast cancer with potential mutations?

The biggest takeaway is doing the appropriate molecular testing or molecular profiling, which is a liquid biopsy, to see if a patient has developed one of these acquired mutations, because that is going to have a huge impact on how we treat that patient. So that would be the most important takeaway, that providers are doing testing with every progression.

The second big takeaway is [adverse] effect profile and what everyone was in agreement [about was] if a patient has a targetable mutation, it's much better to go with the treatment that targets that than use something like, say, chemotherapy, or some of the ADCs [antibody-drug conjugates], which have greater toxicities, even though they may be more effective, like the (ADC).… They have a lot more [adverse] effects,…the efficacy data is amazing, but it's also a much harder treatment to tolerate.

Why is prioritizing AE profiles important when treating patients with HR-positive breast cancer?

The treatment of hormone receptor-positive metastatic breast cancer—it's a different beast. It responds very well to anti-estrogen therapies. It's less aggressive, so it's more of a marathon than a sprint. We want to get as much mileage as possible out of the targeted therapies, before going onto something more aggressive, such as IV chemotherapy or an [ADC].

… Patients who are on first-line treatment, say, with fulvestrant and a CDK4/6 inhibitor, oftentimes they're going to be on that medication for 3 to 5 years without progressing. And so they're kind of used to being on a treatment that has minimal [adverse] effects. There are several good options that we can [use to] target what's driving the growth of the cancer, but also minimizes these [adverse] effects and maintain quality of life, because quality of life is paramount.

This transcript has been edited for clarity and conciseness.

When treating patients with hormone-receptor positive, HER2-negative metastatic breast cancer, mutations necessitate the prioritization of quality of life.

Q&A: Prioritizing QOL Important to Treating HR+, HER2- Metastatic Breast Cancer

As oncology nurses, we are all too familiar with the financial burdens our patients face following a cancer diagnosis. Beyond the physical and emotional toll of a cancer diagnosis, many patients experience significant financial distress as they navigate the costs of care, including insurance co-pays, transportation, and lost wages. To mitigate these challenges, some patients turn to crowdfunding platforms, like GoFundMe, to support themselves and their families during treatment.

Crowdfunding for Gynecologic Oncology Care

O’Connor et al. examined the role of crowdfunding in helping patients with gynecologic cancer offset the financial strain caused by medical and non-medical costs of cancer care, often referred to as financial toxicity.

This cross-sectional study examined 600 GoFundMe crowdfunding campaigns, with 200 each for patients with cervical, uterine, and ovarian cancers. Campaigns were selected based on specific criteria, including a US residency and a single gynecologic cancer diagnosis.

The study analyzed campaign goals, total funds raised, unmet financial needs, and geographic distribution, noting whether campaigns originated from Medicaid expansion or non-expansion states. Financial needs were identified from campaign descriptions, with the authors noting whether crowdfunding was for medical or non-medical expenses or both.

The median campaign goal was $10,000, while the median amount raised was $2828—just 28% of the goal. Only 8.7% of campaigns reached their goal, after a median duration of 54 days online.

Ovarian cancer campaigns generally aimed higher and raised larger amounts of money from more donors compared to cervical cancer campaigns. The median donation of ovarian cancer campaigns was $10,500, compared to $10,000 in cervical cancer (

While ovarian cancer campaigns raised more money than cervical and uterine cancer campaigns, there was no significant difference in the percentage of the campaign goal achieved across cancer types.

Across the 3 cancer types, over 80% of campaigns sought funds for treatment-related costs, such as medical bills. Cervical cancer campaigns more frequently mentioned non-medical costs like lost wages and living expenses, highlighting a potentially broader range of unmet needs compared to uterine and ovarian cancer campaigns.

Many campaigns mentioned inadequate insurance coverage as a major driver of financial need. Around 13.5-20.5% of patients were underinsured.

Across gynecologic cancers, campaigns were fundraising for surgery (29-33.5%), chemotherapy (35-50%), and radiation (2-32%). Cervical cancer campaigns had the highest percentage of requests for radiation therapy (cervical, 32.0%; uterine, 15.5%; ovarian, 2.0%).

Campaigns from non-Medicaid expansion states were overrepresented, particularly for cervical and uterine cancer patients. Non-expansion states, which have more restrictive Medicaid eligibility, leaving many low-income individuals without access to coverage, accounted for 40% of cervical cancer campaigns, 44.5% of uterine cancer campaigns, and 30.5% of ovarian cancer campaigns.

These figures are largely higher than the expected 31.4% based on population distribution, suggesting that patients from non-expansion states may face greater financial burdens and are more likely to turn to crowdfunding to cover medical and non-medical expenses.

The study highlights that while crowdfunding has emerged as a resource to help patients offset costs, it often falls short of meeting their full financial needs, with most campaigns raising only a fraction of their goals.

Nurses can play a pivotal role in mitigating the financial toxicity of cancer care by educating patients about available financial assistance programs, including nonprofit organizations, hospital-based support, and local resources. Additionally, nurses can facilitate discussions around healthcare coverage and Medicaid eligibility—especially for patients in non-expansion states—and connect them with social workers or financial counselors for further assistance.

Emotional support is also vital, as nurses can help patients navigate the complex emotional toll of financial distress, recognizing the significant impact it can have on both mental and physical health.

While crowdfunding may offer some relief, it is not a sustainable solution for most patients. By guiding patients toward more reliable financial support systems, oncology nurses can help reduce financial toxicity and ultimately improve their overall well-being.

O'Connor RM, Huang DS, Rimel BJ, et al. Unmet financial needs among patients crowdfunding to support gynecologic cancer care. 

. 2024;186:199-203. doi:10.1016/j.ygyno.2024.05.017

Oncology nurses can support patients facing financial toxicity by offering guidance on available resources and providing emotional support.

Contributor

Opinion: Crowdfunding Falls Short in Gynecologic Cancer

The FDA approved neoadjuvant therapy with durvalumab (Imfinzi) for use with gemcitabine and cisplatin, followed by adjuvant durvalumab monotherapy after radical cystectomy in adults with muscle invasive bladder cancer (MIBC).

The combination’s efficacy was shown in the randomized, open-label, multicenter phase 3 trial NIAGARA (NCT03732677), in which 1,063 patients were randomized 1:1 to treatment with neoadjuvant durvalumab plus chemotherapy followed by adjuvant durvalumab after surgery or neoadjuvant chemotherapy followed by surgery.

Adverse effects (AEs) were consistent with previous experience with durvalumab plus platinum-based chemotherapy.

The combination has a recommended dose of 1,500 mg of durvalumab every 3 weeks with chemotherapy during neoadjuvant treatment and 1,500 mg of durvalumab monotherapy every 4 weeks in the adjuvant setting for patients with a body weight greater than or equal to 30 kg. Treatment is recommended until patients experience unacceptable toxicity, recurrence, or disease progression that prevents definitive surgery.

Event-free survival (EFS) and overall survival (OS), primary and secondary end points, respectively, of NIAGRA, were statistically significantly improved by the combination therapy.

Median EFS was not reached (NR) in the durvalumab plus chemotherapy arm (95% CI, NR-NR) vs 46.1 months (95% CI, 32.2-NR) in the chemotherapy arm (hazard ratio [HR], 0.68; 95% CI, 0.56-0.82; two-sided 

 < .0001). Median OS was NR in both arms (HR, 0.75; 95% CI, 0.59-0.93; two-sided 

 from a pre-planned interim analysis of NIAGARA that compared the above treatment with durvalumab and chemotherapy to placebo indicated that the combination indicated no new safety signals.

Most patients in both arms of the trial experienced AEs of any cause (99% in the durvalumab arm; 100% in the comparator arm), of which 69% and 68%, respectively, were grade 3 or 4. Serious AEs occurred in 62% and 55% of patients, respectively.

AEs that led to death (5%; 6%), discontinuation of study treatment (21%; 15%), discontinuation of neoadjuvant durvalumab (9%; not applicable [NA]), discontinuation of neoadjuvant chemotherapy (14%; 15%), not undergoing radical cystectomy (1%; 1%), delayed surgery (2%; 1%), and discontinuation of adjuvant durvalumab (8%; NA) occurred.

In both arms, 41% of patients had potentially treatment-related AEs (TRAEs). Of those, 0.6% resulted in death in both arms. Immune-mediated AEs of any grade were reported in 21% of patients taking durvalumab and 3% of patients in the chemotherapy arm. In the adjuvant phase, potential TRAEs were seen in 41% and 6% of patients in the durvalumab and placebo arms, respectively; 6% and 1% of these were grade 3/4. No potential adjuvant TRAEs led to death in either arm.

The most common any-grade AEs were nausea (durvalumab arm, 54%; placebo arm, 49%), anemia (39%; 41%), constipation (39%; 39%), fatigue (36%; 32%), urinary tract infection (30%; 29%), decreased appetite (27%; 25%), neutropenia (26%; 31%), pyrexia (21%; 17%), diarrhea (21%; 14%), vomiting (19%; 18%), blood creatinine increase (19%; 15%), asthenia (18%; 18%), neutrophil count decrease (15%; 14%), and pruritis (15%; 7%).

FDA approves durvalumab for muscle invasive bladder cancer. FDA. March 28, 2025. Accessed March 28, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-muscle-invasive-bladder-cancer

Powles T, Van der Heijden MS, Galsky M, et al. A randomized phase III trial of neoadjuvant durvalumab plus chemotherapy followed by radical cystectomy and adjuvant durvalumab in muscle-invasive bladder cancer (NIAGARA). Presented at: 2024 ESMO Congress; September 13-17, 2024; Barcelona, Spain. Abstract LBA5.

The FDA has approved neoadjuvant durvalumab plus chemotherapy followed by adjuvant durvalumab after radical cystectomy in MIBC.

FDA Approves Perioperative Durvalumab Plus Chemotherapy for MIBC

New data from a real-world, multicenter study published in the 

Journal of Occupational Environmental Hygiene

 show that the Splashblocker portable toilet  cover is effective in reducing the number of particles released in toilet plume aerosols (TPA) in hospitals.

Across 145 toilets in 15 hospitals, the median reduction in particle concentration after implementation of Splashblocker was approximately 100%, with a mean of 101±11% (

 = .0002). Of note, this was regardless of HEPA filter usage. Without a cover, mean particle concentration was 3951#/L±8606 #/L, and the median was 1916 #/L (range: 136-71,959).

As noted in the study, the release of toxins from patient urine has been identified as a significant risk for oncology nurses, and it is recommended by the Oncology Nursing Society that oncology nurses cover toilets with a plastic-backed pad when flushing waste from patients.

“We need to be thinking about all the different avenues of exposure. We’ve gotten pretty good—not perfect—on wearing PPE for administering chemo and disconnecting chemo… But this is an area that, really, we haven’t really done much about,” said Seth Eisenberg, RN, ON, BMTCN, in an interview with Oncology Nursing News. “People have to realize that you need to step up and do things for protection. So that's an obligation for the profession.”

Of note, 94 (85%) toilets demonstrated a particle count reduction of at least 90% when covered with Splashblocker, 107 (97%) showed reduction by at least 80%, and 3 (less than 3%) toilets had a reduction of less than 80%. Investigators found that these toilets had uneven surfaces that cause several gaps of 2-3 mm each between the porcelain and the cover.

“Given the observed variability in effectiveness, future studies might also consider a more nuanced examination of design and environmental factors to optimize particle reduction strategies in healthcare settings,” Eisenberg and Changjie Cai, PhD, noted in the publication of the results.

Floors with HEPA filters were associated with statistically lower ambient particle levels (376±857 #/L) vs floors without HEPA filters (7432±9207#/L). Mixed-effects modeling demonstrated that particle reduction with the Splashblocker in place was significant regardless of floor level (1 through 18), room type (inpatient vs outpatient), geographical state, or flush volume.

Particle counts were measured with a TSI 9306-04 v2 optical particle counter (OPC), which was programmed for a 15-second delay, allowing study personnel to exit the room to reduce further airflow disturbances. The 

 was placed at a distance of 66 cm above the floor to represent the breathing zone of a nurse leaning to flush a toilet.

Measurements were taken for 60 seconds per flush to simulate the greatest amount of time a healthcare worker would typically remain in the room after flushing a patient’s urine. Six bin sizes were studied: 0.3-0.5 µm, 0.5-0.7 µm, 0.7-1.0 µm, 1.0-2.0 µm, 2.0-5.0 µm, and 5.0-25 µm. Particles smaller than 300 nm were not measured.

In an interview with Oncology Nursing News, Eisenberg recounted some of the more remarkable observations he and study personnel found in the differences in rooms when measuring.

“One bathroom we measured…we measured it uncovered first, and then we go back in, usually about 15 minutes later, and measure the ambient [particles] to make sure it went back down to baseline,” said 

. “It never went down. And we actually opened up the door and propped it open with a trash can to try to get it to ventilate. And even after 45 minutes, that bathroom still had a high concentration of particles.”

Researchers examined rooms where patients were not present in order to reduce the effect of airflow disturbances and reduce interruptions to regular care.

Eisenberg S, Cai C. Reducing the particles generated by flushing institutional toilets. Part II: Assessing a portable and reusable toilet cover in U.S. hospitals. 

. 2024;21(12):847-856. doi:10.1080/15459624.2024.2398752

While ambient particle levels differed by HEPA filter status, Splashblocker significantly reduced particles emitted from toilet plume aerosols regardless. 

Randi Kihnel, MSN, APRN, ACCNS-AG

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