Lung cancer patients with extensive-stage small cell lung cancer (ES-SCLC) who have progressed following platinum-based chemotherapy will benefit from the Food and Drug Administration’s (FDA) Fast Track Designation granted to Abdera Therapeutics’ ABD-147, a next-generation precision radiopharmaceutical therapy. According to the company, ABD-147 implements advanced antibody engineering to deliver Actinium-225 to solid tumors expressing DLL3, a protein commonly found on neuroendocrine tumors but rarely expressed on the surface of normal cells or tissues.
“Aggressive neuroendocrine cancers such as SCLC carry a poor prognosis and new treatment options are urgently needed,” said Lori Lyons-Williams, president, CEO, Abdera Therapeutics, in a press release. “These cancers have the most aggressive clinical course of any type of pulmonary tumor and often rapidly metastasize to other parts of the body. We are thrilled the FDA has recognized the potential of ABD-147 to become a transformative treatment option for SCLC and we are excited to begin clinical development and provide ABD-147 to patients in need.”
Lung Cancer Represents 10-15% of Cases in the U.S., with 234,580 Diagnoses and 125,070 Deaths Estimated This Year
In the United States, approximately 10% to 15% of all SCLCs. The American Cancer Society estimates that around 234,580 people will be diagnosed with SCLC in the United States this year, with an estimated 125,070 deaths. In most cases, SCLC occurs in older people, with an average diagnosis age of 70 years; however, a small number of people have been diagnosed under the age of 45 years.
“SCLC is by far the leading cause of cancer death in the US, accounting for about 1 in 5 of all cancer deaths. Each year, more people die of lung cancer than of colon, breast, and prostate cancers combined,” reports the American Cancer Society. “On a positive note, the number of new lung cancer cases continues to decrease, partly because more people are quitting smoking (or not starting). The number of deaths from lung cancer continues to drop as well, due to fewer people smoking and advances in early detection and treatment.”
The chances of males developing SCLC during their lifetime is slightly higher than women. Additionally, Black men are about 12% more likely to develop lung cancer than White men, while Black women have a 16% lower chance of getting it than White women. Despite having a higher chance of developing SCLC, Black men are less likely to develop SCLC than White men.
SCLC Makes Up 50% of Lung Cancer Cases, Leading Cause of Death in Males
In an interview with Targeted Oncology, Qian Wang, MD, MPH explained that SCLC accounts for approximately 50% of all cases of lung cancer, with lung cancer overall remaining the highest cause of death in males.
“We know that SCLC accounts for about 50% of all lung cancer cases,” explained Wang. “Most of the epidemiological studies combine all small cell and non–small cell lung cancers as one group. The incidence and mortality data are both combined, and from looking globally in 2020, we know that lung cancer remains the second most common cancer in males, and the third most common cancer in females. It continues to be a leading cause of cancer-related death in males, and then is the second for females. Approximately in 2020, there were about 1.4 million lung cancer cases in males globally…Among those, approximately 15% of them are small cell lung cancers.”
Abdera plans on initiating a first-in-human Phase I clinical trial for ABD-147 in patients with SCLC or large cell neuroendocrine carcinoma who previously received platinum-based therapy later this year. This trial aims to evaluate the safety, tolerability, and preliminary efficacy of the novel treatment, marking a significant step forward in the fight against aggressive lung cancers.
The designation from the FDA is expected to expedite the development and review process of ABD-147, potentially bringing a much-needed therapeutic option to patients suffering from this aggressive form of cancer. The company’s commitment to advancing treatment options for SCLC and other neuroendocrine tumors underscores the ongoing need for innovation and effective therapies in the oncology landscape.
This development highlights the critical advancements being made in the treatment of lung cancer, especially for those patients with limited options due to the aggressive nature of SCLC. The ongoing research and clinical trials will be crucial in determining the future of ABD-147 and its potential to improve outcomes for patients battling this challenging disease.
Resource: Abdertx, July 16, 2024
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