The Targeted Pulse: Uncover Essential Developments in Breast Cancer, Multiple Myeloma, and NSCLC Treatment and the Latest FDA Approvals

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Cologuard Colorectal Cancer Screening Test Lands FDA Approval

Cologuard Plus has gained FDA approval and is a noninvasive stool DNA test for adults aged 45 years and older to screen for colorectal cancer. This approval is based on data from the BLUE-C study (NCT04144738), which included over 20,000 patients, of whom approximately 40% identified as Hispanic or Latino, Black, Asian, American Indian or Alaska Native, or Pacific Islander. The BLUE-C study found that the Cologuard Plus test significantly outperformed the Polymedco OC-Auto Micro 80iFOB Test in detecting colorectal cancer and related conditions.

“The high colorectal cancer sensitivity and specificity of the Cologuard Plus test gives me confidence in the test’s ability to do just that while simultaneously maintaining a low risk of false positives. This makes the Cologuard Plus test a strong option for first-line screening of average-risk patients,” said Thomas F. Imperiale, MD, professor of medicine at Indiana University School of Medicine, research scientist at the Regenstrief Institute, and principal investigator for the BLUE-C study, in a press release.

Grasping Genomic Profiling Leads to More Personalized Care in Breast Cancer

M. Michele Blackwood, MD, FACS, discussed significant advancements in breast cancer, including genomic testing, screening, and treatments that lead to more personalized care in an interview with Targeted Oncology^TM. Blackwood is the director of breast surgery and women’s oncologic health at RWJBarnabas Health and Rutgers Cancer Institute, as well as head of breast surgery at Cooperman Barnabas Medical Center in New Jersey.

“Genomic profiling of breast cancers is poorly understood. Genomic profiling means that we look at the cancer itself, sometimes right after the biopsy, we take the tumor, and we do a deep dive into the actual genes that cause that cancer to grow and proliferate, and give it its signature… What we found is that many [patients] may not need chemotherapy. It is not about particularly just the size of the tumor and the stage of the tumor and the cancer, but it is about how the tumor behaves,” Blackwood said.

Novel CAR T Therapy Opens New Avenues for Patients With R/R Multiple Myeloma

A novel BCMA-directed chimeric antigen receptor (CAR) T-cell therapy is gaining ground in a phase 1 trial (NCT04720313). The CAR T-cell therapy known as HBI0101 was evaluated in patients with relapsed/refractory multiple myeloma and was academically sourced and produced. In the trial, patients received 3 prior lines of therapy before undergoing HBI0101 CAR T-cell therapy, according to data presented at the 21st International Myeloma Society Annual Meeting.

“HBI0101, an anti-BCMA CAR T-cell therapy demonstrates high efficacy and manageable safety in a frailer and higher-risk population as compared with the registrational studies with commercial products,” lead study author Eyal Lebel, MD, of the Department of Bone Marrow Transplantation and Cancer Immunotherapy at Hadassah Medical Center in Jerusalem, Israel, said in a presentation of the data.

Perioperative Nivolumab Hits an FDA-Home Run for Resectable NSCLC

Neoadjuvant nivolumab (Opdivo) plus chemotherapy, followed by adjuvant nivolumab, received FDA approval for the treatment of operable stage IIA to IIIB non–small cell lung cancer (NSCLC). The approval was based on data from the CheckMate 77T trial (NCT04025879), which compared the approach with placebo. Updated data were presented at the 2024 ESMO Congress, showing a significant improvement in event-free survival.

“It is a major step forward for our patients with NSCLC. We are extremely encouraged to see these results,” Tina Cascone, MD, PhD, associate professor of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center in Houston, and CheckMate 77T investigator, told Targeted OncologyTM in an interview.

“Potential New SOC” For Belantamab Mafodotin Combo inR/R Multiple Myeloma

Belantamab mafodotin-blmf (Blenrep), combined with pomalidomide (Pomalyst) and dexamethasone (BPd), demonstrated a higher percentage of patients achieving meaningful improvements compared with bortezomib (Velcade), pomalidomide, and dexamethasone (PVd) in relapsed/refractory multiple myeloma. Data from the phase 3 DREAMM-8 trial (NCT04484623), presented at the 21st International Myeloma Society Annual Meeting, did not show significant differences in global health status and quality of life. However, these measures were maintained over time, according to patient-reported outcome data.

“Overall, in combination with the significant progression-free survival benefit [generated] with BPd vs PVd, [as] observed in DREAMM-8, these results further support the use of BPd as a potential new standard of care in patients with relapsed/refractory multiple myeloma,” stated presenting author Meletios A. Dimopoulos, MD, professor and chairman of the Department of Clinical Therapeutics at the National and Kapodistrian University of Athens School of Medicine in Greece.

Thank you for joining us for this week’s Targeted Pulse. Look out for more recaps to come.