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Yuhong Dong, M.D., PhD, clinical researcher at Novartis, discusses the benefits of Falun Gong, a Chinese mind-body practice, for patients with cancer.

The Benefits of Falun Gong for Patients With Cancer

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

subscribe to CURE®’s newsletters here.

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®.

Tumor

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., 

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

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.

Conference

Canonical

Blenrep Combo Improves Survival in Relapsed/Refractory Multiple Myeloma 

Former U.S. president Jimmy Carter — who served as the country’s commander in chief from 1977 to 1981 — died at 100 years old, making him the longest-living president in American history.

“My father was a hero, not only to me but to everyone who believes in peace, human rights and unselfish love,” Chip Carter, Jimmy Carter’s son, said in a statement on his death from the Carter Center. “My brothers, sister and I shared him with the rest of the world through these common beliefs. The world is our family because of the way he brought people together, and we thank you for honoring his memory by continuing to live these shared beliefs.”

Carter’s care put a spotlight on the immunotherapy drug, Keytruda (pembrolizumab), which was approved 11 months before his diagnosis of metastatic melanoma in August 2015. After receiving surgery for a mass on his liver and then radiation to treat the brain metastases, Carter went on to receive Keytruda, a monoclonal antibody that works by helping the immune system find and fight cancer.

In December 2015, the former president announced that there were no signs of the original cancer, nor any signs of new ones on a brain MRI. In an August 2016 interview with NBC News, Carter said, “A year ago, I didn’t think I was going to live for two or three weeks. … I was putting on kind of a false, optimistic face.”

In Recent Decades, Immunotherapy Extended Advanced Melanoma Survival from Months to Years

In a story posted on NBC News, Dr. Suresh Ramalingam, executive director of the Winship Cancer Institute of Emory University, where Carter was treated at the time, noted that he and his colleagues were “immensely grateful” for his efforts in raising awareness around immunotherapy.

“When we see patients like President Carter beat their cancer, that is the positive reinforcement that drives us to do even better,” Ramalingam said.

In February 2023, Carter opted to undergo hospice care, a service for individuals who are at the end of their life, with the goal of providing comfort, reducing pain and addressing physical and psychological needs for both patients and providers. Carter’s wife, Rosalynn Carter, who had dementia, also entered hospice care in November 2023, before her death on Nov. 19.

The Carter Center, a nonprofit established by the former president and his wife, Rosalynn, announced on Feb. 18, 2023, “After a series of short hospital stays, former US President Jimmy Carter today decided to spend his remaining time at home with his family and receive hospice care instead of additional medical intervention. He has the full support of his family and his medical team.”

Many people across social media and via public comments have made statements on Carter’s death.

“With his compassion and moral clarity, he worked to eradicate disease, forge peace, advance civil rights and human rights, promote free and fair elections, house the homeless and always advocate for the least among us,” President Joe Biden and First Lady Jill Biden said in a joint statement. “He saved, lifted and changed the lives of people all across the globe.”

President-elect Donald Trump also commented on Truth Social by writing, “The challenges Jimmy faced as president came at a pivotal time for our country, and he did everything in his power to improve the lives of all Americans. For that, we all owe him a debt of gratitude.”

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

Jimmy Carter, the longest-living U.S. president, passed away at 100. His battle with metastatic melanoma highlighted the effectiveness of Keytruda, an immunotherapy drug. After treatment, Carter announced cancer remission in 2015. His case raised awareness about immunotherapy's potential in cancer treatment. In 2023, Carter chose hospice care, focusing on comfort in his final days. His death prompted tributes from global leaders, acknowledging his contributions to peace, human rights, and healthcare. The Carter Center continues his legacy of humanitarian efforts and advocacy for the underserved.

Former U.S. President Jimmy Carter called attention to the immunotherapy drug Keytruda, which was used to successfully treat his cancer. 

Former U.S. President Jimmy Carter Dies at 100

Throughout December, the Food and Drug Administration (FDA) approved several oncology drugs for the treatment of cancers including pancreatic, lung and skin.

Here is a select list of cancer therapies approved by the FDA last month.

Bizengri for Some with NSCLC, Pancreatic Adenocarcinoma

 (zenocutuzumab-zbco), the first systemic therapy for patients with advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC) or pancreatic adenocarcinoma whose tumors have a NRG1 gene fusion and have progressed after prior systemic therapy. This accelerated approval applies to both NSCLC and pancreatic adenocarcinoma.

The eNRGy study evaluated Bizengri's effectiveness in 64 adults with advanced or metastatic NRG1 fusion-positive NSCLC and 30 adults with advanced or metastatic NRG1 fusion-positive pancreatic adenocarcinoma whose disease had progressed after standard treatment. In the NSCLC group, the objective response rate (ORR) was 33%, with a median duration of response (DOR) of 7.4 months. The pancreatic adenocarcinoma group had a 40% ORR, with a DOR ranging from 3.7 to 16.6 months.

Imfinzi for Limited-Stage Small Cell Lung Cancer

 (durvalumab) was approved for adults with limited-stage small cell lung cancer who have not experienced disease progression following concurrent platinum-based chemotherapy and radiation therapy.

The ADRIATIC trial showed that Imfinzi significantly improved both overall survival and progression-free survival (PFS) compared to placebo. Median overall survival was 55.9 months for patients receiving Imfinzi versus 33.4 months for those receiving placebo. Similarly, median PFS was 16.6 months with Imfinzi compared to 9.2 months with placebo.

Unloxcyt for Locally Advanced, Metastatic Skin Cancer Subset

The FDA granted approval to Unloxcyt (cosibelimab-ipdl) for the treatment of patients with locally advanced or metastatic cutaneous 

 (a type of skin cancer) who are not candidates for curative surgery or radiation. Unloxcyt is a PD-L1-blocking antibody, a type of immune checkpoint inhibitor that helps the body's immune system target and destroy cancer cells.

In a clinical trial, researchers assessed the ORR and DOR to the treatment. The ORR was 47% in 78 patients with metastatic cutaneous squamous cell carcinoma and 48% in 31 patients with locally advanced disease. The median DOR was not reached in the metastatic group, indicating that the response was durable, and most patients had not experienced disease progression at the time of data analysis. Among those with locally advanced disease, the median DOR was 17.7 months.

The FDA has approved Ensacove (ensartinib) for the first-line treatment of adults with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic NSCLC. This approval is specifically for patients who have not previously received an 

 demonstrated that Ensacove significantly improved PFS compared to Xalkori. The median PFS with Ensacove was 25.8 months, more than double the 12.7 months observed with Xalkori.

Ryoncil Receives FDA Approval for Children With GVHD

 (remestemcel-L-rknd) was approved for children aged two months and older with steroid-refractory acute graft-versus-host disease. This is the first mesenchymal stromal cell therapy to receive FDA approval.

By day 28 of the study, the overall response rate reached 70%, with 30% of patients achieving a complete response and 41% achieving a partial response. The median DOR was 54 days, with responses lasting from seven days to at least 159 days.

The FDA recently approved several oncology drugs, including Bizengri for NRG1 fusion-positive NSCLC and pancreatic adenocarcinoma, Imfinzi for limited-stage small cell lung cancer, Unloxcyt for advanced cutaneous squamous cell carcinoma, Ensacove for ALK-positive NSCLC, and Ryoncil for pediatric steroid-refractory acute GVHD. These approvals highlight significant advancements in targeted therapies and immunotherapies, offering improved outcomes in terms of objective response rates, progression-free survival, and overall survival across various cancer types. These developments underscore the ongoing progress in personalized cancer treatment strategies.

The FDA approved several drugs in December for the treatment of diseases, including pancreatic adenocarcinoma, lung cancer, skin cancer and graft-versus-host disease.

Yuhong Dong, M.D., PhD

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