Victoria Johnson joined the MJH Life Sciences in 2020 and has written for NeurologyLive, CGTLive, and now HCPLive. You can reach her at vjohnson@mjhlifesciences.com

Victoria Johnson

Lungcast: Current Perspectives on Treatment of Small Cell Lung Cancer with Jacob Sands, MD

Small cell lung cancer (SCLC) remains one of the most formidable challenges in thoracic oncology. Accounting for roughly 15% of all lung cancers, SCLC is defined by its rapid growth, early metastatic potential, and high recurrence rates.

 While non–SCLC has seen transformative advances in targeted therapies and immunotherapy, SCLC has historically lagged behind, with chemotherapy and radiation long serving as the primary treatment backbone. Despite initial responses to therapy, outcomes have remained poor, with survival rates trailing far behind those seen in other lung cancer subtypes.

In recent years, however, a wave of research has begun to change this narrative. Advances in immunotherapy, novel chemotherapeutic agents, and innovative approaches such as bispecific antibodies and vaccines are reshaping treatment strategies. Landmark trials have introduced new standards of care, particularly in limited-stage disease, and ongoing studies continue to push the field toward more durable control and improved survival.

 The exploration of biomarkers and disease subtypes, once elusive in SCLC, is also beginning to show promise, raising the possibility of more personalized approaches to treatment.

, host Albert Rizzo, MD, is joined by Jacob Sands, MD, thoracic medical oncologist at Dana-Farber Cancer Institute and Associate Chief of the Lowe Center for Thoracic Oncology and Assistant Professor of Harvard Medical School, to discuss the evolving landscape of SCLC therapy. Sands, who also leads the small cell lung cancer clinical research program at Dana-Farber, shares insights into the latest therapeutic advances, the most promising investigational strategies, and why the outlook for patients with this historically intractable disease is finally beginning to brighten.

"There is more going on right now in the development of drugs for SCLC that looks encouraging, that looks exciting, than the culmination of everything up to this point so far. And the science is getting so fast that I think in the next decade ahead, we're going to see some very big advances in the field, and I'm just so optimistic looking forward now," Sands said. "If we talk in a year, there's going to be so much more to discuss."

Lungcast is a monthly respiratory news podcast series hosted by Albert Rizzo, MD, chief medical officer of the ALA, and produced by 

Editor's Note: Rizzo's disclosures include Pfizer, AstraZeneca, and Genentech. Sands' disclosures include Pfizer

AstraZeneca, Medtronic, Daiichi Sankyo/UCB Japan, Sanofi, Boehringer Ingelheim, PharmaMar, Guardant Health, AbbVie, Gilead Sciences, Lilly, and G1 Therapeutics.

Rudin CM, Brambilla E, Faivre-Finn C, Sage J. Small-cell lung cancer. 

. 2021;7(1):3. Published 2021 Jan 14. doi:10.1038/s41572-020-00235-0

Takahashi T, Yamanaka T, Seto T, et al. Prophylactic cranial irradiation versus observation in patients with extensive-disease small-cell lung cancer: a multicentre, randomised, open-label, phase 3 trial. 

Trigo J, Subbiah V, Besse B, et al. Lurbinectedin as second-line treatment for patients with small-cell lung cancer: a single-arm, open-label, phase 2 basket trial. 

Videos

This episode of Lungcast features a discussion on emerging treatment approaches for SCLC.

Santerus AG has received Breakthrough Device Designation from the United States (US) Food and Drug Administration for its NucleoCapture blood purification technology for the treatment of severe, treatment-refractory systemic 

"This second FDA Breakthrough Device Designation validates our scientific approach and highlights the urgent unmet need for safe, targeted therapies in refractory autoimmune disease," Andrew Daniel Aswani, PhD, Chief Medical Officer of Santersus, said in a statement.

 "We believe NucleoCapture has the potential to transform patient outcomes across a range of devastating conditions where current treatment options are limited."

NucleoCapture is an extracorporeal therapeutic apheresis column designed to selectively remove cell-free DNA (cfDNA) and neutrophil extracellular traps (NETs) from patient plasma. NETs are increasingly recognized as key drivers of inflammation, thrombosis, autoimmunity, and multi-organ injury. NucleoCapture may offer a novel, non-immunosuppressive treatment option for patients with a variety of diseases that have been refractory to current standard-of-care therapies. For people with active SLE, NucleoCapture is being investigated as an adjunct to standard therapy.

Santerus AG previously received Breakthrough Device Designation for NucleoCapture for the treatment of sepsis. In addition to sepsis and septic shock, the company is also investigating the device for the prevention of graft injury and dysfunction and neurodegeneration, including Alzheimer disease and other neurodegenerative disorders. Santersus is preparing to initiate pivotal clinical trials in both the U.S. and Europe for all potential indications.

The latest advances in lupus research were presented at July’s 

European Alliance of Associations for Rheumatology (EULAR) Congress 2025

 held in Barcelona, Spain. One high impact trial presented there was the phase 3 PHOENYCS GO trial which is evaluating 

 (DZP) in people with moderate-to-severe SLE, positive data from which were presented by Eric F. Morand, MBBS, Head of the Monash Health Rheumatology Unit, Monash University, Australia.

“[PHOENYCS GO] is a positive phase 3 trial - evidence does not get much better than this. Trials in SLE are really hard to do, as the disease is heterogenous and endpoints disfavor success - this means a positive result has basically happened against the odds and is meaningful,” Morand told 

“How DZP fits into the treatment paradigm remains to be seen as the pipeline has lots of other interesting medicines in development which together will change the landscape very greatly in the next handful of years. Regardless, these data strongly suggest that CD40L has a real place in our care paradigm.”

Morand and colleagues found that at Week 48, 40.9% of participants receiving DZP plus standard of care (SOC) achieved low disease activity, more than double the rate in the SOC-only group (19.6%; nominal* 

 <.0001). As early as Week 12, significantly more participants on DZP plus SOC achieved low lupus disease activity state (LLDAS) versus SOC alone (nominal* 

 <.05). Additionally, 23.6% of the DZP group maintained low disease activity in ≥50% of visits over 48 weeks, compared to 15.9% with SOC alone (nominal* 

 = .1042). At Week 48, 19.2% of participants receiving DZP achieved remission (DORIS criteria), compared to 8.4% in the SOC-only group (nominal* 

“As we get used to the patient profiles that may respond differently to differently targeted medicines, or differences in safety profile that may influence our choice based on patients’ comorbidities, things will get clearer. On the basis that DZP clearly increases attainment of treatment goals, it will have a significant role if it gains regulatory approval,” Morand said.

Santersus AG Receives Second US FDA Breakthrough Device Designation for NucleoCapture in Systemic Lupus Erythematosus. News release. Santerus AG. August 26, 2025. 

https://finance.yahoo.com/news/santersus-ag-receives-second-us-193500630.html?guccounter=1&guce_referrer=aHR0cHM6Ly93d3cuZ29vZ2xlLmNvbS8&guce_referrer_sig=AQAAAFFl8bRntQ7jzDSpQT2yEMwphCwzqvrvZs241SXjVkD_ec9ZU_lCcuz_YDwbH85DGqLdJQBRTBgZCRaVDXVuOK-e5ujLsGyvF2AfIK4wk6SG9WiJ4q2x8B5jCAb5kkzdCfux7HQ1QnYz3-WRthhflUqBD1575ABdC2Qmzxetg15i

Dapirolizumab Pegol Phase 3 Data in SLE Presented at the Annual European Congress of Rheumatology (EULAR) Show Improvement in Fatigue and Reduction in Disease Activity. Biogen. News release. June 12, 2025. 

https://investors.biogen.com/news-releases/news-release-details/dapirolizumab-pegol-phase-3-data-sle-presented-annual-european

Articles

Santerus AG's NucleoCapture technology has received FDA Breakthrough Device Designation for treating severe systemic lupus erythematosus (SLE), marking its second such designation. NucleoCapture, an extracorporeal apheresis column, targets cell-free DNA and neutrophil extracellular traps, offering a non-immunosuppressive treatment option for refractory diseases. Concurrently, the PHOENYCS GO trial demonstrated promising results for dapirolizumab pegol (DZP) in SLE, showing significant improvements in disease activity and remission rates. These advancements underscore the evolving landscape of SLE treatment, with potential regulatory approval for DZP anticipated.

Santerus AG is preparing to initiate clinical trials of its blood purification technology in a variety of indications.

NucleoCapture Gets FDA Breakthrough Designation for Systemic Lupus Erythematosus

Travere Therapeutics has announced the US Food and Drug Administration (FDA) approval of an updated Risk Evaluation and Mitigation Strategy (REMS) labeling for sparsentan (Filspari) for the treatment of 

According to an August 27, 2025, press release from the Company, the update reduces the frequency of liver function monitoring from monthly to every 3 months from the onset of treatment with sparsentan and removes the embryo-fetal toxicity (EFT) monitoring requirement from the REMS.

“[Sparsentan] is becoming a foundational treatment for people living with IgA nephropathy, giving patients and their families hope for slowing the progression of their disease,” Jula Inrig, MD, chief medical officer of Travere Therapeutics, said in a statement.

 “Today’s approval of streamlined monitoring requirements reflects the strong safety profile of [sparsentan] established to date across clinical and real-world use, simplifying access for patients.”

As described in the release from Travere, the reduction of sparsentan liver monitoring REMS from monthly to every 3 months from the onset of treatment was supported by safety data from post-marketing surveillance as well as the phase 3 PROTECT Study in IgAN, the phase 3 DUPLEX Study, and the phase 2 DUET Study in 

focal segmental glomerulosclerosis (FSGS)

The FDA determined that the REMS requirement for EFT for sparsentan was no longer necessary following an analysis of human pregnancy data compiled from the use of ERA medicines from the last 2 decades.

The endothelin and angiotensin II receptor antagonist was granted accelerated approval for the treatment of IgAN in February 2023 based on clinically meaningful and statistically significant improvements in proteinuria compared to an active comparator in the phase 3 PROTECT study. It gained full approval in September 2024 based on 2-year confirmatory results from PROTECT, making sparsentan the second therapeutic to receive full approval for IgAN after Calliditas Therapeutics’ budesonide (Tarpeyo) delayed release capsules.

A supplemental New Drug Application (sNDA) for sparsentan in FSGS is currently under review with the FDA, with a Prescription Drug User Fee Act target action date of January 13, 2026. The sNDA submission was supported by results from the phase 3 DUPLEX Study and the phase 2 DUET Study, 2 of the largest head-to-head interventional studies conducted to date in adult and pediatric patients with FSGS.

While DUPLEX achieved its pre-specified interim FSGS partial remission of proteinuria endpoint with statistical significance at 36 weeks, it did not achieve the primary efficacy eGFR slope endpoint over 108 weeks of treatment. 2-year results from the study were published in the 

 and showed that sparsentan delivered clinically meaningful benefit at 108 weeks with significant proteinuria reduction, higher rates of partial and complete remission, and a lower rate of end-stage kidney disease compared to the active control.

DUET met the primary efficacy endpoint for the combined treatment group, demonstrating a greater than 2-fold reduction in proteinuria compared to irbesartan. Additionally, sparsentan was well-tolerated with a safety profile that was consistent across all clinical trials conducted to date and comparable to the maximally dosed active control, irbesartan, including no drug-induced liver injury and no fluid overload.

If approved, sparsentan would be the first and only approved medicine indicated for FSGS.

Travere Therapeutics. Travere Therapeutics Announces U.S. FDA Approves REMS Modification for FILSPARI® (sparsentan) in IgA Nephropathy. August 27, 2025. Accessed August 27, 2025. 

https://ir.travere.com/press-releases/news-details/2025/Travere-Therapeutics-Announces-U-S--FDA-Approves-REMS-Modification-for-FILSPARI-sparsentan-in-IgA-Nephropathy/default.aspx

Brooks A. FDA Approves Travere Therapeutics’ Sparsentan to Slow Kidney Function Decline in Adult Primary IgAN. HCPLive. September 5, 2024. Accessed August 27, 2025. 

https://www.hcplive.com/view/fda-approves-travere-therapuetics-sparsentan-for-proteinuria-reduction-in-adult-primary-igan

Brooks A. FDA Accepts Sparsentan (Filspari) sNDA for Focal Segmental Glomerulosclerosis. HCPLive. May 15, 2025. Accessed August 27, 2025. 

https://www.hcplive.com/view/fda-accepts-sparsentan-filspari-snda-for-focal-segmental-glomerulosclerosis

The FDA has approved an updated REMS labeling for sparsentan (Filspari) in treating IgA nephropathy, reducing liver function monitoring frequency and removing embryo-fetal toxicity monitoring. This decision is based on safety data from clinical trials and post-marketing surveillance. Sparsentan, an endothelin and angiotensin II receptor antagonist, received full approval for IgAN in 2024. A supplemental New Drug Application for sparsentan in focal segmental glomerulosclerosis is under FDA review. If approved, it would be the first approved treatment for FSGS, demonstrating significant proteinuria reduction and safety.

The REMS label update reduces the frequency of liver function monitoring and removes the embryo-fetal toxicity monitoring requirement.

FDA Approves REMS Label Update for Sparsentan (Filspari) in IgA Nephropathy

Redefining Bronchiectasis Research and Management With First FDA Approval

 RX Review Special Report, Albert Rizzo, MD, and James Chalmers, MBChB, PhD, discuss how the August 2025 

 (marketed as Brinsupri), the first disease modifying therapy for bronchiectasis, may shift therapeutic goals in the field beyond exacerbation reduction and toward long-term preservation of pulmonary health.

Rizzo and Chalmers then discuss how trial endpoints in the field may evolve to focus on disease modification and slowing decline, and may include measures such as CT imaging and radiographic markers of airway damage, complementing traditional exacerbation rates and lung function outcomes.

Both experts reflect on the broader impact of this therapeutic advance. Chalmers anticipates increased recognition and diagnosis of bronchiectasis now that a targeted therapy is available, similar to the paradigm shift seen in interstitial lung disease after antifibrotic approvals. He stresses the need for collaboration across primary care, community pulmonology, and specialty centers to manage a condition that affects an estimated one million patients in the U.S. Importantly, he underscores that brensocatib should be viewed as one element of comprehensive care—alongside airway clearance, infection management, and evaluation of underlying causes—rather than a standalone solution.

"I think we're going to see a lot more attention to bronchiectasis. It's really been very much a Cinderella condition... and the availability of a new therapy, it gets people interested, it gives people a reason to diagnose it, because there's something powerful and effective that they can do about it," Chalmers said.

Part 1: Shifting Bronchiectasis Treatment Toward Disease Modification

Brensocatib Brings DPP1 Inhibition to the Bronchiectasis Field

Part 3: Understanding Brensocatib's Mechanism and Safety in Bronchiectasis

Part 4: Brensocatib's Place in Clinical Care of Bronchiectasis

Part 5: Redefining Bronchiectasis Research and Management With First FDA Approval

is a pulmonologist at ChristianaCare Pulmonary Associates at the ChristianaCare in Newark, Delaware, and clinical assistant professor of medicine at Thomas Jefferson University Medical School, Philadelphia. Triple board certified in internal medicine, pulmonary, critical care and sleep medicine, he also served as the former Chief Medical Officer of the American Lung Association.

is a Clinical Professor (Teaching and Research) of Respiratory Research, Respiratory Medicine and Gastroenterology, at  University of Dundee, United Kingdom, where he also serves as Asthma and Lung UK Chair of Respiratory Research. He was a primary investigator on Insmed's ASPEN trial of brensocatib.

Editor's note: Rizzo's disclosures include Pfizer, AstraZeneca, and Genentech. Chalmer's disclosures include AstraZeneca, Boehringer Ingelheim, Genentech, Gilead, Grifols Biologicals, Insmed, Novartis, and Zambon.

Johnson V. FDA Approves First Bronchiectasis Therapy, Brensocatib, for Ages 12 and Up. 

https://www.hcplive.com/view/fda-approves-first-bronchiectasis-therapy-brensocatib-12-up

In this video, the last in a 5-part series, panelists discuss their future outlook on bronchiectasis management.