The Targeted Pulse: Immunotherapy’s Success in Triple-Negative Breast Cancer and Key FDA Actions to Know

Immunotherapy/ICI Expands Use in Triple-Negative Breast Cancer

The use of immune checkpoint inhibitors in combination with immunotherapy has expanded in the treatment of triple-negative breast cancer (TNBC), prompting researchers to identify distinct molecular subtypes for more personalized approaches. During the 2024 San Antonio Breast Cancer Symposium, Heather McArthur, MD, MPH, and Thomas Grinda, MD, MSc, presented key breakthroughs in this field. Trials supporting these advancements include the phase 3 KEYNOTE-355 trial (NCT02819518), the phase 2 SPARK study (NCT04734262), and the phase 2 COMPLEMENT trial (NCT05174832), among others.

“The data look encouraging,” said McArthur, addressing data from the COMPLEMENT trial. “It’s interesting to note that patients with conversion to TNBC, [ie,] those who initially have hormone receptor–positive disease, seem to derive less benefit from this maintenance strategy than those who were consistently triple negative. [That’s demonstrated by] the doubling of progression-free survival,” said McArthur, professor, Department of Internal Medicine, UT Southwestern Medical Center, and clinical director, breast cancer, and Komen Distinguished Chair in Clinical Breast Cancer Research at Harold C. Simmons Comprehensive Cancer Center in Dallas, Texas. Access the full article exploring this breakthrough in TNBC here.

Encorafenib Combo Shows “Encouraging Response” in BRAF V600E–mutated mCRC

The combination of encorafenib (Braftovi), cetuximab (Erbitux), and mFOLFOX6 chemotherapy (fluorouracil, leucovorin, and oxaliplatin) improved the overall response rate (ORR) in patients with BRAF V600E–mutated metastatic colorectal cancer (mCRC) compared with chemotherapy alone. These findings, from the phase 3 BREAKWATER trial (NCT04607421), were presented at the 2025 Gastrointestinal Cancer Symposium. In this article, Scott Kopetz, MD, PhD, FACP, offers deeper insight into the clinical implications of these positive results for mCRC treatment.

“The response rate was certainly encouraging, but as part of the pre-planned analysis, there was a fairly early interim look at overall survival, and I think that showed really impressive trends to improvement, where we saw an early separation of the survival curves,” explained Scott Kopetz, MD, PhD, FACP, in an interview with Targeted Oncology^TM.

Kopetz is deputy chair for Translational Research and a professor in the Department of Gastrointestinal (GI) Medical Oncology, Division of Cancer Medicine; leader of the Department of Cancer Center Support Grant, GI Program; TRACTION medical director in the Division of Therapeutics Discovery Division; and associate vice president for Translational Integration at The University of Texas MD Anderson Cancer Center in Houston, Texas.

CAR T-Cell Therapy, CTD402, has received IND clearance in T-ALL/LBL

CTD402, a CD7-targeted universal chimeric antigen receptor T-cell therapy, has received FDA clearance as an investigational new drug (IND). This designation applies to both pediatric and adult patients with relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoma. A single-arm, open-label phase 1b/2 trial will evaluate the optimized dose of CTD402 in this patient population.

“We are delighted that CTD402 has received IND clearance from the US FDA for a phase 1b/2 trial with a simplified dose-finding design, accelerating our clinical development timeline in the US,” stated Jiangtao Ren, PhD, president and chief scientific officer of Bioheng, in a press release. “[Investigator-initiated trials] study results showed an impressive [ORR], alongside a favorable safety profile. These results validate our ANSWER platform's ability to deliver both rapid therapeutic impact and reduced patient risk, positioning CTD402 as a potential best-in-class therapy for T-cell malignancies.”

Tislelizumab/Chemotherapy Approval Expands Options for Advanced ESCC

The combination of tislelizumab-jsgr (Tevimbra) and platinum-containing chemotherapy has received FDA approval as a first-line treatment for patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC). This approval applies to those with a tumor PD-L1 expression of 1 or higher and is based on data from the phase 3 RATIONALE-306 trial (NCT03783442). In the trial, the combination was compared with chemotherapy alone and demonstrated a significant improvement in overall survival.

“The added effect of tislelizumab to chemotherapy was shown in the patients with chemotherapy naive advanced and recurred ESCC. The magnitude of efficacy was consistent with the former study with chemotherapy plus an immune checkpoint inhibitor, but tislelizumab showed efficacy even for the patients who were PD-L1 negative,” Ken Kato, MD, PhD, chief of the department of head and neck, and esophageal medical oncology and gastrointestinal medical oncology at the National Cancer Center Hospital in Tokyo, Japan, told Targeted Oncology^TM.

February 2025 FDA Approvals/Designations: Everything You Need to Know

This article provides a complete rundown of all the FDA approvals and designations that occurred in the month of February. If it was a busy month, this summary will get you up to speed with key highlights and links to full coverage of each FDA action.

Some of the key developments include a breakthrough device designation for a new artificial intelligence tool that helps to stratify patients with non–small cell lung cancer into high- and low-risk categories. In addition, nogapendekin alfa (Anktiva) and CAR-NK (PD-L1 t-haNK) received regenerative medicine advanced therapy status for their potential to reverse lymphopenia in patients with metastatic pancreatic cancer. This designation applies to those undergoing chemotherapy or radiotherapy for this cancer type. For the full rundown, access the article here.

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

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