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I find myself enormously inadequate to fully explain why I think this lady, my wife, should be selected as a Multiple Myeloma Hero, but whether she is or not, she is my hero. 

Myeloma Heroes Come in Many Forms

Adding the PARP inhibitor veliparib to treatment with temozolomide did not significantly extend overall survival (OS) in patients with newly diagnosed, MGMT-hypermethylated glioblastoma, according to findings from a randomized, phase 2/3 clinical trial published in 

Although the investigational combination was well tolerated and had an acceptable elevation in grade 3 or 4 hematologic toxicities, the median overall survival (OS) in patients treated in the phase 3 analysis was 24.8 months for the placebo arm compared with 28.1 months in the veliparib arm. Therefore, this difference in survival did not meet the investigation’s prespecified efficacy end point. Notably, study authors added that there was separation of the survival curves that favored the investigational arm over 24 and 48 months of follow-up.

Additionally, there was no significant difference in progression-free survival (PFS) between the treatment groups and no identified statistically significant differences regarding OS across stratification variables of age, ECOG performance status, extent of resection, and tumor-treating field (TTF) use.

“This randomized clinical trial did not demonstrate a significant OS benefit for patients with MGMT-hypermethylated glioblastoma treated with adjuvant temozolomide combined with veliparib. While PFS was superimposable, there was a trend for higher survival with veliparib plus temozolomide treatment at intermediate points,” study authors wrote in the 

 article. “The results for each of these studies could be explained if a more effective experimental treatment produced a deeper nadir in tumor cell burden.”

Standard treatments for glioblastoma, which is the most common primary malignant brain tumor, includes surgery and radiotherapy with concurrent temozolomide followed by adjuvant temozolomide and TTFs. Even in patients with MGMT-hypermethylated glioblastoma, therapy resistance leads to tumor progression and death. However, there is a strong rationale to evaluate PARP1 inhibitors as chemosensitizing agents due to prior improvement in survival following treatment of patients with breast, ovarian or prostates cancers.

“Veliparib is in a category of drugs called a PARP inhibitor, which works by not allowing cancer cells to repair damaged DNA. When these damages build up in a cell, it can lead to cell death which is the goal of these types of drugs,” Dr. Priya U. Kumthekar explained in a news release from Northwestern University.

Kumthekar, who is one of the study authors, currently serves as an associate professor of medicine in the Division of Hematology and Oncology and is a member of the Robert H. Lurie Comprehensive Cancer Center at Northwestern University Feinberg School of Medicine, in Evanston, Illinois.

“When glioblastoma is MGMT promoter-methylated, this means that it is more susceptible or more sensitive to the effects of alkylating chemotherapy, or in this case temozolomide. While patients who have tumors that are MGMT promoter-methylated fare better than those whose tumors do not possess this, the current treatment regimen remains a noncurative option,” she added in the same news release.

Based on this rationale, investigators aimed to answer this question: Does the PARP inhibitor veliparib enhance the efficacy of temozolomide in patients with newly diagnosed, MGMT promoter hypermethylated glioblastoma?

Taking a Deeper Dive Into the Phase 2/3 Trial

Patients aged 18 and older were eligible for enrollment onto the phase 2/3 study so long as they had MGMT-hypermethylated glioblastoma without 1p/19q co-deletion, completion of concurrent temozolomide treatment and radiotherapy with recovery from treatment, platelet nadir levels of 75,000/mm

 or greater, an ECOG performance status of 2 or less, and adequate organ function and seizure control.

Eligible participants were enrolled and randomly assigned between treatment arms between Dec. 15, 2014, and Dec. 15, 2018, onto the study. Patients were stratified by age, ECOG status, extent of resection and planned use of TTF.

PFS served as the primary end point of the phase 2 portion of the study while OS served as the primary end point for phase 3.

Notably, study authors noted that, “The treatment groups were well balanced regarding baseline variables.”

In the phase 2 portion of the study, 322 patients were randomized to treatment, while 125 patients were added in the phase 3 accrual, making a total of 447 patients in the final analysis of the phase 3 trial. The median age range for these patients was 60 years old and a majority of patients were male.

"The results reported in this randomized clinical trial highlight the importance of developing more precise predictive biomarkers to identify the subset of patients with the greatest temozolomide-sensitizing potential. ... The present study potentially provides a road-map for a highly efficient clinical evaluation strategy for PARP1-selective or other novel chemosensitizing strategies in newly diagnosed glioblastoma,” study authors concluded.

For more news on cancer updates, research and education, don’t forget to 

subscribe to CURE®’s newsletters here.

The addition of the PARP inhibitor veliparib to temozolomide treatment did not significantly improve overall survival (OS) in patients with newly diagnosed, MGMT-hypermethylated glioblastoma, as shown in a phase 2/3 trial. Although the combination was well tolerated, the OS difference between the veliparib and placebo arms was not statistically significant. Progression-free survival (PFS) was similar across treatment groups. The study underscores the need for precise predictive biomarkers to identify patients who may benefit from temozolomide-sensitizing strategies, offering a framework for future clinical evaluations.

Veliparib plus temozolomide did not significantly extend overall survival in patients with newly diagnosed, MGMT-hypermethylated glioblastoma.

Tumor

Veliparib and Temozolomide Combo Does Not Significantly Extend Survival for Patients With Glioma

Emily Armstrong is one of the best nurses I have had the privilege to have worked with. Her level of wisdom and care for her patients is unmatched.

I was a newer oncology nurse, and she was always my go-to resource when we worked together. She was knowledgeable on the different reasons why we administer drugs over a certain amount of time and how different regimens differ. Her knowledge of chemotherapy extended beyond the basics of nursing knowledge, and she knew many pharmaceutical and non-pharmaceutical interventions when treating oncologic symptoms. She was always willing to share her knowledge with me.

Now that we work at different clinics and I am more experienced, she frequently brings up in conversation differences of practices, and questions what is most beneficial or what is evidence-based. If it is an outdated practice, she pushes for change and questions the practice with her management. This increases the quality and improves patient experience wherever she is working. She is an excellent clinician and an asset to our profession.

Emily fights very hard for her patients. She will adamantly advocate for a patient when she sees the need. I have seen this on too many different occasions to provide a specific example. Her expertise allows her to confidently do this despite her sometimes-timid personality. Emily is especially helpful, always willing to grab her patients a blanket, position them or give them encouragement. Emily constantly works for the best possible outcome for her patients and increases the level of the nursing professionalism wherever she practices.

Rose Sawyer has been serving as an oncology nurse at Denver Health for nearly 10 years and is a key player in cancer care delivery for our patients. Denver Health serves as the safety net hospital for Denver County, where the majority of our patients live below the federal poverty line and are covered by either Medicare or Medicaid, or do not have insurance.

Prior to joining the Denver Health Oncology clinic team, Rose served as an infusion nurse for several years. The skills and experience she obtained during that time have had an incredible impact on the care she provides to our patients. She is particularly passionate about and masterful in providing our patients education about their systemic treatment. With each new treatment start, she has an appointment with the patient to educate them about their treatment and to answer their questions that have not yet been covered.

Her time as an infusion nurse has not only given her expertise in the various side effects of the medications, but also in the expectations for infusion days and the expected timing of side effects. She teaches each of her patients all this information, and in doing so builds an incredible relationship with her patients that lasts throughout their care and beyond. Her patients trust her and look to her for help as they experience the day-to-day symptoms the chemotherapy can cause and the emotional toll that cancer has on them.

Rose is a solid rock for her patients and a consistent source of encouragement, advice and love for her patients as they undergo some of the most difficult times of their lives. She provides peace in a time of tumult when nothing is sure. The impact Rose has on their lives is invaluable, allowing her patients to have the best opportunity to endure their treatment and achieve their hoped-for outcomes.

Ruth Cummings has been an oncology nurse for more than 30 years. She has experience in both inpatient and outpatient settings. The majority of this experience has been in a clinic setting which has expanded and evolved through the years.

She is a member of the Oncology Nursing Society and took it upon herself to pursue ONC certification before it was a standard requirement for employment in oncology. This achievement attests to her expertise in oncology nursing.

Ruth has demonstrated great compassion and commitment for her career and to her patients. She has worked tirelessly to care for hematology and oncology patients. She collaborates closely with the team to ensure that the care provided to each veteran is individualized according to clinical needs.

In addition, Ruth can often be seen going above and beyond the requirements of her job to ensure that patient needs are met by checking and rechecking orders and treatment modalities. She can often be seen bringing in items to provide diversional activities for patients including decorations, books, magazines, puzzle books, etc. She can also be seen bringing in food items to help those who have difficulty eating. She wants to make sure that patients are comfortable during every treatment. She loves what she does and loves her patients.

Ruth has shown tremendous compassion to each and every patient and family. For example, there was a young veteran who was diagnosed with testicular cancer. Ruth took care of this young man through his treatment regimen. They developed an everlasting connection and bond that has lasted through the years. The veteran recovered from his cancer and makes every effort to seek out Ruth during every visit to the Veterans Health Administration (VA) for other healthcare needs.

Ruth is dedicated to the VA mission — “To care for him who shall have borne the battle, and for his widow, and his orphan” — by serving and honoring the men and women who are America’s veterans. No matter what the situation, Ruth arrives early and stay late to ensure that every patient is taken care of. She is an “extraordinary healer” who is worthy of this recognition and duly deserves it.

Emily Armstrong, Rose Sawyer, and Ruth Cummings exemplify exceptional oncology nursing through their dedication, expertise, and patient advocacy. Emily's extensive knowledge and commitment to evidence-based practices enhance patient care and professional standards. Rose's experience as an infusion nurse allows her to provide comprehensive patient education and emotional support, fostering trust and strong patient relationships. Ruth's compassion and commitment to individualized care, along with her proactive approach to patient comfort, highlight her dedication to the VA mission and her role as an extraordinary healer in oncology nursing.

Emily Armstrong, Rose Sawyer and Ruth Cummings, oncology nurses, are recognized for their dedication, expertise and patient advocacy at Denver Health.

Nurses Leading the Way in Cancer Care

Polycythemia Vera: How to Diagnose

Video content above is prompted by the following:

What might make these patients, or their doctors, consider that their symptoms could be caused by PV?

What is the typical symptom burden at diagnosis?

What tests might a patient undergo in order to confirm a PV diagnosis?

What are some challenges faced in diagnosing PV?

A panelist discusses how patients with polycythemia vera (PV) often present with diverse symptoms ranging from fatigue and itching to cardiovascular complications, leading doctors to conduct specific diagnostic tests including complete blood counts, JAK2 mutation analysis and bone marrow biopsies, although diagnosis can be challenging due to symptom overlap with other conditions and varying presentation patterns.

Video Series

Telix Pharmaceuticals has submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for the kidney cancer imaging PET drug product, Zircaix (TLX250-CDx; 

Zr- girentuximab), according to a press release from the company.

“We are pleased to be progressing the BLA for [Zircaix], which has been granted Breakthrough designation, and may therefore be eligible for priority review. Telix continues to target a full U.S. commercial launch in 2025 addressing a major unmet medical need for patients with suspected clear cell renal cell carcinoma [ccRCC],” Kevin Richardson, chief executive officer of Precision Medicine at Telix, stated in the press release.

ccRCC is classified as the most common and aggressive form of kidney cancer, and if approved, the investigational drug product will serve as a non-invasive way to diagnosis and characterize patients. Furthermore, if approved, Zircaix will also be the first and only targeted PET agent specifically for kidney cancer to be commercially available in the U.S.

The confirmatory, prospective, open-label, multi-center study evaluated the sensitivity and specificity of Zircaix imaging and its ability to non-invasively detect ccRCC in adult patients with indeterminate renal masses, scheduled for partial or total nephrectomy.

The patients’ nephrectomies were performed at institutional discretion any time following the PET imaging visit but was not done any later than 90 days post-administration of 89Zr-TLX250. 

Patients eligible for enrollment onto the trial consisted of anyone 18 years of age or older with imaging evidence of a single indeterminate renal mass of 7 centimeters or smaller in the largest diameter and who were scheduled for lesion resection as part of regular diagnostic work-up within 90 days from planned 89Zr-TLX250 administration, as well as sufficient life expectancy to justify nephrectomy. 

Exclusion criteria consisted of renal mass known to be a metastasis of another primary tumor; active renal malignancy requiring therapy during the time frame of the study; chemotherapy, radiotherapy or immunotherapy within a four-week period prior to planned investigative treatment administration; and serious non-malignant disease that may interfere with the objectives of the study.

In total, 300 patients were evaluated, of which 284 were evaluable for enrollment. These patients met all primary and secondary end points, and showed an 86% sensitivity, an 87% specificity and a 93% positive-predictive value for ccRCC across three independent radiology readers.

“Telix believes [that these data] demonstrated the ability of [Zircaix] to reliably detect the clear cell phenotype and provide an accurate, non-invasive method for diagnosing and characterizing ccRCC. Confidence intervals exceeded expectations amongst all three readers, showing evidence of high accuracy and consistency of interpretation,” the company cited in the press release.

Notably, the company shared that following the 60-day administrative review of the application by the regulatory agency, the FDA is expected to advise the Prescription Drug User Fee Act (PDUFA) goal date.

For more news on cancer updates, research and education, don’t forget to

Telix Pharmaceuticals has submitted a Biologics License Application to the FDA for Zircaix, a PET imaging drug for kidney cancer, which has received Breakthrough designation. Zircaix targets clear cell renal cell carcinoma (ccRCC), the most common and aggressive kidney cancer form. The phase 3 ZIRCON trial demonstrated Zircaix's high sensitivity, specificity, and positive-predictive value in detecting ccRCC. The trial involved 300 patients, with 284 meeting all endpoints. The FDA's 60-day review will determine the Prescription Drug User Fee Act goal date for potential approval.

A Biologics License Application has been submitted to the FDA for treatment with the kidney cancer imaging PET drug product, Zircaix®.

BLA Has Been Submitted For Kidney Cancer Imaging PET Product Zircaix

Patients with relapsed/refractory multiple myeloma experienced significant improvements in overall survival (OS) when treated with Blenrep (belantamab mafodotin) in combination with Velcade (bortezomib) and dexamethasone (BVd) versus those treated with Darzalex (daratumumab) plus Velcade and dexamethasone (DVd), trial results have shown.

Updated data from the phase 3 DREAMM-7 trial was presented during the 2024 ASH Annual Meeting and Exposition.

At a median follow-up of 39.4 months, the median OS was not reached (NR) in both the BVd (243 patients) and DVd (251 patients) arms. The predicted median OS based on modeling is 84 months with BVd versus 51 months with DVd. The estimated 24-month survival rates in the respective arms were 79% and 67%; these respective rates at 36 months are 74% and 60%.

Moreover, deeper responses were achieved and maintained with Blenrep vs Darzalex. The objective response rate (ORR) with BVd was 83.1% versus 71.3% with DVd. The median duration of response (DOR) with BVd was more than double that achieved with DVd, at 40.8 months and 17.8 months, respectively.

The percentage of those who achieved a complete response or better and minimal residual disease (MRD) negativity with a sensitivity of 10

 was 25.1% in the BVd arm versus 10.4% in the DVd arm. The percentage of patients who experienced a very good partial response or better and MRD negativity with a sensitivity of 10

 in the respective arms was 38.7% and 17.9%, respectively.

Treatment benefit derived with BVd was also maintained after subsequent antimyeloma therapy. The median time to second objective disease progression (PFS2) with BVd was NR versus 33.4 months with DVd.

“BVd demonstrated an early, sustained and statistically significant OS benefit in a head-to-head trial against the [Darzalex] combination,” Dr. Vania Hungria of Clinica Sao Germano, in Sao Paulo, Brazil, said in a presentation of the data. “DREAMM-7 has now shown statistically significant [progression-free survival (PFS)], OS, DOR and MRD negativity benefits compared with DVd. [As such,] these results further support the use of BVd as a potential new standard of care in relapsed or refractory multiple myeloma.”

The randomized, open-label, phase 3 DREAMM-7 study enrolled patients with multiple myeloma who were at least 18 years of age and received at least one prior line of therapy and experienced documented progressive disease (PD) after their most recent line. Patients could not have previous exposure to anti-BCMA therapy, nor could they have disease that was refractory to or intolerant of Darzalex or Velcade.

Participants were randomly evenly assigned to receive Blenrep at a dose of 2.5 milligrams per kilogram (mg/kg) intravenously (IV) every three weeks paired with Velcade and dexamethasone versus Darzalex at a dose of 16 mg/kg IV weekly for cycles 1 to 3 and then every three weeks for cycles 4 to 8. For cycles 9 and later, those in the investigative and control arms received single-agent Blenrep at 2.5 mg/kg IV every three weeks or Darzalex monotherapy at 16 mg/kg IV every four weeks, respectively. Treatment continued until the study concluded, consent was withdrawn, PD, death or intolerable toxicity.

PFS served as the trial’s primary end point, and at a median follow-up of 28.2 months this was met. The median PFS of 36.6 months with BVd versus 13.4 months with DVd translated to a 59% reduction in the risk of disease progression or death. At the time of the primary analysis, median OS was NR in both arms, but a strong trend favored the BVd regimen. In November 2024, the FDA accepted a biologics license application seeking the approval of BVd in patients with multiple myeloma who have received at least 1 prior therapy based on DREAMM-7 data. The target action date is July 23, 2025.

Key secondary end points of the trial included OS, DOR and MRD. End points were tested in the following hierarchy: PFS, followed by OS and DOR, followed by MRD. Additional secondary end points of interest included CR rate, ORR, clinical benefit rate, time to response, time to progression, PFS2 and adverse effects (side effects), particularly ocular findings.

Of the total 494 patients enrolled, 243 were assigned to the BVd arm and 251 were assigned to the DVd arm; 242 and 246 patients, respectively, received treatment. A higher percentage of patients on the BVd arm remained on therapy versus those on the DVd arm, at 25% and 15%, respectively. The most common reason for discontinuation in the BVd arm was PD (30%), followed by toxicity (21%), physician decision (13%), patient withdrawal (10%), loss to follow-up (less than 1%) and protocol-defined stopping criteria reached (less than 1%).

The data cutoff date of the analysis shared during the meeting was Oct. 7, 2024. At this time point, the median duration of exposure to BVd was 15.9 months versus 12.8 months in the DVd arm. Baseline characteristics and prior treatments received proved to be balanced across the arms, according to Hungria, who added that approximately half of patients received one prior line of therapy.

“More patients in the DVd group discontinued treatment early due to progression and went on to receive a subsequent antimyeloma therapy,” Hungria said. “The most common subsequent therapy in both arms include immunomodulatory drugs like [Revlimid (lenalidomide)] and [Pomalyst (pomalidomide)]. Of patients who received subsequent therapies, more than half received anti-CD38 monoclonal antibodies immediately after BVd, and [Kyprolis (carfilzomib)] was given often after DVd.”

Regarding safety, any-grade side effects (AEs) occurred in all patients in the BVd and DVd arms; these effects were related to study treatment for 100% and 95% of patients, respectively. Grade 3 (severe) or 4 (life-threatening) AEs occurred in 95% and 78% of patients, respectively, with 92% and 67% related to study treatment. In the BVd arm, AEs led to dose delays or reductions for 95% and 75% of patients, respectively; in the DVd arm, these rates were 76% and 59%. AEs resulted in permanent discontinuation of treatment for 32% of those given BVd and 19% of those who received DVd. Serious AEs related to any study treatment were experienced by 21% and 13% of patients and serious AEs proved to be fatal for 11% and 8% of patients.

“AEs were consistent with the known safety profile for the individual agents in each regimen,” Hungria noted. “Although the BVd arm had numerically higher overall rates of grade 3 or 4 and serious AEs, when adjusting for total treatment exposure, safety results were generally comparable between arms. There were more deaths due to myeloma in the DVd vs the BVd arm.”

She added that thrombocytopenia was more common in the BVd arm, even when adjusted for exposure. Overall, infection rates were similar between the arms and consistent with the primary analysis. In the BVd and DVd arms, exposure-adjusted rates of infections per 100 person-years were 43.75% and 48.71% for all-grade events, and 19.89% versus 14.29%, respectively, for grade 3 or higher events.

“About two-thirds of patients did not have a clinically meaningful drop in best-corrected visual acuity, [BCVA]” Hungria said. “Overall, the ocular safety profile is consistent with the primary analysis. Nearly all patients with worsening of vision to 20/50 had resolution to normal baseline or improvement of the first event. The 2% of patients with an ongoing event had insubstantial follow-up to assess for resolution.” In the BVd arm, blurred vision was the most frequent ocular event experienced; 68% experienced an any-grade event and 24% experienced a grade 3 or 4 event. Ten percent of patients discontinued due to an ocular event.

“The interval between doses increased with time due to dose modification, from initial three weeks up to 12 weeks,” Hungria noted. “Despite the extended dose intervals, the responses were maintained.” Twenty-three percent of patients experienced 20/50 or worse ocular events in the first three months and prevalence generally dropped thereafter. Notably, the rate of treatment discontinuation due to these events was low, she concluded.

Belantamab mafodotin, bortezomib, and dexamethasone vs daratumumab, bortezomib, and dexamethasone in relapsed/refractory multiple myeloma: overall survival analysis and updated efficacy outcomes of the phase 3 DREAMM-7 trial” by Dr. Vania Hungria et al., 

Patients with relapsed/refractory multiple myeloma showed improved overall survival (OS) with Blenrep (belantamab mafodotin) combined with Velcade (bortezomib) and dexamethasone (BVd) compared to Darzalex (daratumumab) with Velcade and dexamethasone (DVd). The phase 3 DREAMM-7 trial indicated a predicted median OS of 84 months for BVd versus 51 months for DVd. BVd also demonstrated superior objective response rate (ORR), duration of response (DOR), and minimal residual disease (MRD) negativity. Safety profiles were consistent, though BVd had higher rates of grade 3/4 adverse events.

William H. Greene, PhD

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