The Targeted Pulse: The Practice-Changing Approval of Afami-cel for Advanced Synovial Sarcoma, Buprenorphine Offers Pain Relief for Bone Marrow Transplant, and More

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FDA approves afami-cel for advanced synovial sarcoma and dostarlimab is now approved for all advanced endometrial cancers. In addition, buprenorphine offers improved pain management for bone marrow transplant patients, subcutaneous amivantamab reduces AEs, and SRS offers benefits over WBRT for SCLC.

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“Practice-Changing Approval”: Afami-cel for Advanced Synovial Sarcoma

Tecelra (afamitresgene autoleucel; afami-cel) has received accelerated FDA approval for treating advanced synovial sarcoma. This innovative T-cell therapy targets the MAGE-A4 protein and is supported by data from the SPEARHEAD-1 trial (NCT04044768).

“For synovial sarcoma, this is super important and a practice-changing approval,” Sandra P. D’Angelo, MD, a medical oncologist at Memorial Sloan Kettering Cancer Center, told Targeted OncologyTM in an interview. “Afami-cel offers a remarkable improvement upon the standard of care, so it is a promising and exciting option for our patients. It also provides a lot of hope and excitement for patients with rare cancers as it shows the ability of our sarcoma community to work together to identify these patients, treat these patients, and bring this drug over the finish line.”

Sketch of female reproductive system

Dostarlimab Is Now Approved for All Advanced Forms of Endometrial Cancer

The FDA has extended the approval of dostarlimab-gxly (Jemperli) plus standard-of-care chemotherapy to all forms of advanced endometrial cancer, which also includes proficient mismatch repair/microsatellite stable tumors. The extended approval is based on data from the RUBY/ENGOT-EN6/GOG3031/NSGO trial (NCT03981796), which compared the combination with placebo/chemotherapy, reporting statistically significant results.

“These data confirm dostarlimab plus carboplatin/paclitaxel is a new standard-of-care for patients with primary advanced or recurrent endometrial cancer, regardless of their mismatch repair status,” said Matthew A. Powell, MD, professor of obstetrics and gynecology, and chief in the Division of Gynecologic Oncology, at Washington University in St. Louis, in Missouri, in an oral presentation of the data during the 2024 Society of Gynecologic Oncology Meeting.

Sketch of blood cells

Opioids to Buprenorphine: A New Era in Managing Bone Marrow Transplant Pain

Research presented by Mayuko Sakae, MD, at the 2024 Multinational Association of Supportive Care in Cancer (MASCC) demonstrated that buprenorphine shows promise in helping manage severe pain more effectively than traditional opioids for those with sickle cell disease undergoing bone marrow transplantation (BMT). The use of buprenorphine can more effectively manage escalating pain as it minimizes opioid dose escalation and the related adverse effects (AEs). In this article, Sakae talks with Targeted OncologyTM to explain the data leading to enhance quality care for patients undergoing BMT.

“The number 1 key finding is that buprenorphine, an opioid pain medication with unique pharmacological properties, can provide effective pain management in patients suffering from uncontrolled pain with severe and complex pain history with significantly less opioid [adverse] effects,” Sakae explained. “This means buprenorphine often causes less respiratory depression, less gastrointestinal AEs such as constipation, nausea, less euphoria and craving, and less depressant- and stress-causing neurotransmission compared with traditional full agonists. Sakae is an assistant clinical professor at City of Hope in the Department of Supportive Care Medicine.

Sketch of human lungs

Subcutaneous Amivantamab Reduces AEs in NSCLC Treatment

Subcutaneous (SC) amivantamab-vmjw (Rybrevant) significantly reduced infusion-related reactions and administration time compared with the intravenous (IV) formulation as shown in the PALOMA-2 study (NCT05498428). In the study, patients with previously untreated advanced non–small cell lung cancer harboring EGFR mutations were given the SC amivantamab and lazertinib (Leclaza) and achieved a similar response rate to the historical IV combination. In this article Nicolas Girard, MD, PhD, thoracic oncologist at the Curie Institute in Paris, France, and study investigator on PALOMA-2, discussed findings and implications from the study.

“Now, the question is how to move forward with the administration of amivantamab. It can be done intravenously, for sure,” Girard explained. “But given the fact that those patients are usually young patients still working and wanting to have a normal quality-of-life, it is good to have this [subcutaneous] formulation in terms of organizational purposes. It can be done at home.”

Sketch of human brain

Breaking the Mold: SRS Offers Benefits Over WBRT for SCLC Brain Metastases

Stereotactic radiosurgery (SRS) has emerged as the standard-of-care for patients with limited brain metastases, replacing whole brain radiotherapy (WBRT) in many cases due to its targeted approach and reduced AEs. However, this standard has not been widely adopted for small cell lung cancer (SCLC) due to concerns about potential neurologic decline and adverse outcomes. A phase 2, multi-institutional, prospective study (NCT03391362) addressed this gap by evaluating the efficacy of SRS in patients with SCLC and limited brain metastases. Ayal Aizer, MD, MHS, head of the division of central nervous system radiation oncology at Brigham and Women’s Hospital/Dana-Farber Cancer Institute, discussed the study findings.

“I think the main takeaway is that at this moment, we still do not know which is the best option for patients with small cell lung cancer and brain metastases,” Aizer relayed. “We await 2 randomized trials, which will more definitively answer that question. I think what our study shows… is that it is probably reasonable to offer stereotactic radiation for patients with SCLC who have never received prophylactic cranial radiation and who have a limited number of brain metastases.”

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

Here is last week’s Targeted Pulse in case you missed it.

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