The Targeted Pulse: Agent Exhibiting PFS Increases, Guideline Changes, Approvals, and More


T-DXd enhances survival in HR+/HER2-low breast cancer, and immunotherapy combo is recommended for advanced SCLC. We also highlight recent FDA approvals and challenges associated with legislative changes.

Sketch of cancer in breast tissue

T-DXd Reaches New PFS Highs in HR+/HER2-Low Breast Cancer

Fam-trastuzumab deruxtecan-nxki (Enhertu; T-DXd) triumphed, showing a significant improvement to progression-free survival when compared with standard-of-care chemotherapy. The patient population included in the phase 3 DESTINY-Breast06 trial (NCT04494425) were those with hormone receptor (HR)-positive, HER2-low, metastatic breast cancer following 1 or more lines of endocrine therapy.

“DESTINY-Breast06 shows that [T-DXd] could become a new standard of care for patients with HER2-low and HER2-ultralow metastatic breast cancer following 1 or more lines of endocrine therapy. These data underscore the potential for treatment with [T-DXd] across the spectrum of HR-positive breast cancer, further redefining the treatment of metastatic breast cancer,” said Susan Galbraith, executive vice president, oncology research and development, AstraZeneca, in a press release.

Sketch of human lungs

Latest Guidelines Advocate Immunotherapy Combination for Advanced SCLC

New guidelines recommend pairing chemotherapy with immunotherapy followed by maintenance immunotherapy for patients with small cell lung cancer. This is because the combination method has demonstrated a longer-term survival than chemotherapy alone. Several trial data contributed to the updated, including the phase 3 IMpower133 trial (NCT02763579).

“The primary clarification is that in limited-stage small cell lung cancer, initiating chemotherapy promptly is crucial. These individuals are prone to rapid disease progression and can deteriorate quickly. The objective is to commence chemotherapy as soon as possible, and then consider incorporating radiation therapy [in] the second cycle,” Gregory Peter Kalemkerian, MD, said in an interview with Targeted Oncology. Kalemkerian is a clinical professor, associate division chief for faculty development and education, and the associate director of the hematology/oncology fellowship program at the University of Michigan Health in Ann Arbor.

HLX02 Pockets FDA Approval for HER2-Positive Cancer Management

Trastuzumab-strf (HLX02) gains traction with an achieved FDA approval for adjuvant treatment in HER2-overexpressing breast cancer. The approval also extends to patients with HER2-overexpressing metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

The agent, a biosimilar of trastuzumab (Herceptin, Hercessi), received approval based on a series of head-to-head trials, including a global, multicenter, phase 3 trial (NCT03084237) assessing the efficacy, safety, and immunogenicity of HLX02 compared to Herceptin.

“We aspire to deliver one of the deepest portfolios of biosimilars to patients and providers alike, and to help the US health system achieve significant savings,” Binish Chudgar said in the press release. Chudgar is vice chairman and managing director of Intas Pharmaceuticals.

Sketch of female reproductive system

Tisotumab Vedotin Is Granted Full FDA Approval in Advanced Cervical Cancer

A full FDA approval was given to tisotumab vedotin-tftv (Tivdak) for the treatment of patients with recurrent or metastatic cervical cancer whose disease has progressed on or after first-line therapy. The approval is based on data from the phase 3 innovaTV 301 trial (NCT04697628) where the agent was compared with investigator’s choice of chemotherapy as a second- or third-line treatment among those in the intent-to-treat population. In contrast, tisotumab vedotin-tftv showed a reduction in death.

“In oncology care, we want to find the best treatment that treats all patients. But without doing that, we want to take positive steps. This is a tremendous step in the right direction,” Brian Slomovitz, MD, gynecologic oncologist, director of gynecologic oncology, Mount Sinai Medical Center, Miami Beach, Florida, and primary investigator of the innovaTV 301 trial, said in an interview with Targeted OncologyTM.

Recent Legislative Changes Affect Community Oncology Care

According to Ben Jones, concerning legislative changes being made in Washington, DC are creating financial strains on community oncology practices. In the full article, Jones discusses some of the repercussions and challenges felt by those in the field, highlighting the pitfalls in the legislative changes. Jones is vice president of government relations and public policy for McKesson, The US Oncology Network and presented “The Politics of Oncology: Legislative Updates & Predictions from Capitol Hill,” during the 2024 Community Oncology Conference.

“There [is] a pretty wide range of issues ranging from physician reimbursement, Medicare reform, value-based care, how the government responded to Change Healthcare’s cyberattack, enhancing drug rights and policies that are starting to filter through but are focused on the implementation of the Inflation Reduction Act, and how Congress plans to respond to the increasing pressure for greater transparency of pharmacy benefit manager,” Jones said in an interview with Targeted OncologyTM.

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

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