Lung Cancer | Symptoms, Causes, Treatment and Survival Rates

Futile Immunotherapy For Cancer Grows More Common

Providing immunotherapy for patients with metastatic cancer that proves quickly terminal is increasing, with more than 1 in 14 immunotherapy treatments in 2019 initiated within 1 month of death, according to a large retrospective cohort study.

Proportions of patients with metastatic disease who started immunotherapy within 1 month of death rose over the study periods (the time of FDA approval until 2019) from 0.8% to 4.3% for melanoma, 0.9% to 3.2% for non-small cell lung cancer (NSCLC), and 0.5% to 2.6% for kidney cell carcinoma.

By 2019, these end-of-life–initiated treatments represented 7.3% of all immunotherapy treatments, reported Sajid A. Khan, MD, of the Yale School of Medicine in New Haven, Connecticut, and colleagues.

Moreover, the study showed that this practice is more common at non-academic and lower-volume health care centers, and that these types of facilities have worse survival rates.

"The rate of end-of-life–initiated immunotherapy is increasing," Khan and colleagues wrote in JAMA Oncology. "More research on the benefit and value of these therapies in patients with advanced-stage disease is needed."

Their study covered 242,371 patients from the National Cancer Database: 20,415 with melanoma, 197,331 patients with NSCLC, and 24,625 patients with kidney cell carcinoma, all at stage IV.

Patients' mean age was 67.9, with 42.5% older than 70; 56.0% were men, and 29.3% received immunotherapy

Study periods for each cancer type started the year immediately following FDA approval of the first immune checkpoint inhibitor for the treatment of stage IV disease for that particular indication (2012 for melanoma, and 2016 for NSCLC and kidney cell carcinoma).

Khan's group found that, when stratifying by facility type and volume, fewer patients treated at academic and high-volume facilities started immunotherapy at the end of life for all three cancer types. And survival on immunotherapy at these institutions was significantly better: odds of death within 1 month of starting immunotherapy were lower by 31% at an academic or high-volume center (OR 0.69, 95% CI 0.65-0.74, P<0.001) versus a non-academic facility, and by 30% (OR 0.70, 95% CI 0.65-0.76, P<0.001) relative to very low-volume centers.

Across all three cancer types, those patients with three or more organs involved in metastatic disease were 3.8-fold more likely (95% CI 3.1-4.7, P<0.001) to die within 1 month of immunotherapy initiation than those with lymph node involvement only.

Khan and colleagues also found that patients with advanced disease treated at high-volume and academic facilities had longer survival compared with those treated at very low-volume or non-academic centers, regardless of whether or not they received immunotherapy, with overall risk-adjusted mortality rates lower by 10%-33%.

In an editorial accompanying the study, Michael Hoerger, PhD, of Tulane University in New Orleans, and two colleagues highlighted the study's finding that treatment with immunotherapy was associated with a 5%-18% absolute increase in 5-year survival across the three cancer types. But academic centers had 5%-9% better absolute 5-year survival than non-academic centers, and high-volume health care centers had 4%-13% better absolute survival than very low-volume centers.

Furthermore, Hoerger and colleagues suggested that since "academic and high-volume centers may be referred more complex cases," these figures may underestimate the survival gap.

"These health care center associations with survival are profound," the editorialists wrote. "These differences in immunotherapy use and patient survival can be understood through a systemic health care disparities lens. Patients who are experiencing health care disparities may be undertreated early in the disease course due to barriers to access and utilization and may also receive interventions less likely to offer benefit near death. [The findings in this study] fit that pattern."

Mike Bassett is a staff writer focusing on oncology and hematology. He is based in Massachusetts.

Disclosures

Khan reported grants from National Institutes of Health Career Development Award during the conduct of the study.

Several co-authors reported relationships with industry.

The editorialists had no disclosures.

Primary Source

JAMA Oncology

Source Reference: Kerekes D, et al "Immunotherapy initiation at the end of life in patients with metastatic cancer in the US" JAMA Oncol 2024; DOI: 10.1001/jamaoncol.2023.6025.

Secondary Source

JAMA Oncology

Source Reference: Hoerger M, et al "Initiating immunotherapy in the treatment of stage IV cancers in the month before death -- a health care disparities lens" JAMA Oncol 2024; DOI: 10.1001/jamaoncol.2023.5932.

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Rylan DeStefano

Rylan DeStefano is an assistant editor working for CURE®, and has been with MJH Life Sciences since June of 2023. Rylan is a graduate from Muhlenberg College. When she's not writing, Rylan loves to read, travel and spend time with family and friends.

Kiromic BioPharma Reports Favorable Early Safety And Tolerability Data From First Patient Enrolled In The Phase 1 Deltacel-01 Clinical Trial

Company Executives Available to Meet with Investment Professionals January 8-10 in San Francisco

HOUSTON–(BUSINESS WIRE)–$KRBP #BIOTECH—Kiromic BioPharma, Inc. (OTCQB: KRBP) ("Kiromic" or the "Company"), a clinical-stage, fully-integrated biotherapeutics company using its proprietary DIAMOND® artificial intelligence and data mining platform to develop cell therapies with a focus on immuno-oncology, reports favorable safety and tolerability from the first patient 23 days after Deltacel™ infusion in the Phase 1 clinical trial for treatment of stage 4 metastatic non-small cell lung cancer (NSCLC) at Beverly Hills Cancer Center, located in Beverly Hills, California, USA. Specifically, laboratory test results and observations by clinical staff identified no adverse events and confirmed that Deltacel is being well tolerated with initial safety profile. Continued monitoring of safety and tolerability will provide more insights as the trial enrolls additional patients.

Kiromic expects to report preliminary efficacy results from this patient by the end of January 2024. Two more patients are expected to be enrolled between January and February 2024.

"Our first-in-human clinical trial of Deltacel is proceeding very well and on plan," said Pietro Bersani, Chief Executive Officer of Kiromic. "With no adverse events observed during the first 23 days post-treatment, we have strong indication that Deltacel is well tolerated. We look forward to discussing updates with members of the investment community during our meetings next week in San Francisco, concurrent with the 42nd Annual J.P. Morgan Healthcare Conference."

Investment professionals interested in meeting with Mr. Bersani, Chief Financial Officer Brian Hungerford and Chief Scientific Officer Dr. Leonardo Mirandola at LHA's offsite event being held January 8-10 should contact Tirth Patel at tpatel@lhai.Com.

"We are very pleased to see favorable initial safety and tolerability data from the first patient treated in our Deltacel-01 study," said Dr. Afshin Eli Gabayan, Medical Oncologist, Medical Director, and Principal Investigator at Beverly Hills Cancer Center. "Seeing no adverse events reported 23 days after Deltacel infusion provides early validation that this novel cell therapy is well tolerated when combined with low dose radiation for lung cancer patients. We look forward to further evaluating optimal dose level, efficacy, and long-term safety outcomes as additional patients are enrolled and treated. If this promising initial data is replicated in more patients, Deltacel could become a new alternative treatment option for NSCLC patients."

About Deltacel-01

In Kiromic's open-label Phase 1 clinical trial, titled "Phase 1 Trial Evaluating the Safety and Tolerability of Gamma Delta T Cell Infusions in Combination With Low Dose Radiotherapy in Subjects With Stage 4 Metastatic Non-Small Cell Lung Cancer" (NCT06069570), patients with stage 4 NSCLC will receive two intravenous infusions of Deltacel with four courses of low-dose, localized radiation over a 10-day period. The primary objective of the study is to evaluate safety, while secondary ones include objective response, progression-free survival, overall survival, time to progression, time to treatment response and disease control rates.

About Deltacel™

Deltacel (KB-GDT-01) is an investigational gamma delta T-cell (GDT) therapy currently in the Deltacel-01 Phase 1 trial for the treatment of NSCLC. An allogeneic product consisting of unmodified, donor-derived gamma delta T cells, Deltacel is the leading candidate in Kiromic's GDT platform. Deltacel is designed to exploit the natural potency of GDT cells to target solid cancers, with an initial focus on NSCLC, the most prevalent type of lung cancer and representing about 80% to 85% of lung cancer cases. Data from two preclinical studies demonstrated Deltacel's favorable safety and efficacy profile when it was combined with low-dose radiation.

About Kiromic BioPharma

Kiromic BioPharma, Inc. Is a clinical-stage, fully integrated biotherapeutics company using its proprietary DIAMOND® artificial intelligence (AI) 2.0 target discovery engine to develop and commercialize cell therapies focusing on immuno-oncology. Kiromic is developing a multi-indication allogeneic cell therapy platform that exploits the natural potency of Gamma Delta T-cells to target solid tumors. Kiromic's DIAMOND® AI is where data science meets target identification to dramatically compress the years and hundreds of millions of dollars required to develop a live drug. The Company maintains offices in Houston, Texas. To learn more, visit www.Kiromic.Com and connect with us on Twitter and LinkedIn.

About Beverly Hills Cancer Center

As a private, academic, community-based cancer center, Beverly Hills Cancer Center not only provides the latest state-of-the-art cancer treatments all under one roof, but also provides leading clinical trials and research, attracting patients globally. By providing access to groundbreaking clinical trials, the Beverly Hills Cancer Center offers patients the opportunity to participate in the most advanced cancer treatments currently in development in the world. Beverly Hills Cancer Center is composed of an internationally recognized multidisciplinary medical team consisting of Medical Oncologists, Radiation Oncologists, Radiologists, Hematologists and Internists who provide exceptional patient care and support services including a robust and highly efficient team of clinical research professionals. More information is available on: www.BHCancerCenter.Com.

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Kiromic makes such forward-looking statements pursuant to the safe harbor provisions of the United States Private Securities Litigation Reform Act, Section 21E of the Securities Exchange Act of 1934, as amended, and other federal securities laws. All statements other than statements of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as: "will," "potential," "could," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may," or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements regarding: Kiromic's ability to achieve its objectives and Kiromic's financing strategy and availability of funds. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in our Annual Report on Form 10-K for the year ended December 31, 2022, and as detailed from time to time in our other SEC filings. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance, or events and circumstances reflected in the forward-looking statements will be achieved or occur. Moreover, neither we nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements. Such forward-looking statements relate only to events as of the date of this press release. We undertake no obligation to update any forward-looking statements except to the extent required by law.

Contacts

Kiromic BioPharmaLinda Phelan Dyson, MPH

Global Head, Corporate Communications

ldyson@kiromic.Com281-468-7683

LHA Investor RelationsTirth T. Patel

tpatel@lhai.Com212-201-6614

Beverly Hills Cancer CenterSharon Neman

Chief Strategy Officer

SN@BHCancerCenter.Com310-432-8925

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