The Targeted Pulse: Subcutaneous Nivolumab Moves Forward, Experts Discuss IO/TKI regimens for RRC, and More


A BLA for subcutaneous nivolumab in solid tumors, lenvatinib becoming primary treatment in thyroid cancer, and expert discussions on IO/TKI combos in RCC. We also cover positive results from acalabrutinib combination in MCL and pembrolizumab combination in HER2-positive gastric cancer.

Subcutaneous Nivolumab Advances in Various Solid Tumors With Accepted BLA

The FDA has accepted the biologics license application for the subcutaneous formulation of nivolumab (Opdivo) coformulated with human hyaluronidase. The phase 3 CheckMate -67T (NCT04810078) trial data support the acceptance, which evaluated subcutaneous nivolumab vs its intravenous (IV) formulation.

“…If approved by the FDA, the subcutaneous administration of nivolumab would provide patients and their physicians with a new option that delivers the same well-known benefits as IV [nivolumab] but with the improved convenience of an injection administered in 3 to 5 minutes rather than a 30- to 60-minute infusion,” Gina Fusaro, PhD, vice president, global program lead, Bristol Myers Squibb, said in a press release.

Sketch of human thyroid

Lenvatinib Earns Frontline Designation in RAI-Refractory DTC

Lenvatinib (Lenvima) is a primary treatment option for patients with radioactive iodine-refractory differentiated thyroid cancer. Lori J. Wirth, MD provides a comprehensive analysis explaining the data from the phase 3 SELECT trial (NCT01321554), which supported the approval, and shares tips for its use.

“It is important to make sure that patients are in good shape prior to initiating lenvatinib. Patients do need to have good blood pressure control before initiating lenvatinib. Hypertension can be seen early in the course of starting therapy,” Writh said. Wirth is associate professor of medicine at Harvard Medical School and medical director of the Center for Head and Neck Cancers at Massachusetts General Hospital, both in Boston.

Sketch of human kidneys

Expert Discussions on IO/TKI Combinations in Advanced RCC

In a Case-Based Roundtable® event moderated by Shilpa Gupta, MD, experts sit down to discuss the various immune oncology/ tyrosine kinase inhibitors (TKI) combinations used to treat patients with clear cell metastatic renal cell carcinoma. The discussion spans from assessing factors that determine intermediate or high-risk for progression to addressing the real-world experience with the various regimens.

“There’s a significant survival benefit [with these combinations], especially in intermediate- and poor-risk patients, but the reason we’re losing that benefit is because of the immunotherapy, in my opinion. If you look at ipilimumab/nivolumab, the benefit in survival vs TKI is maintained...because [the patient is] on immunotherapy to begin with,” said Aneel Chowdhary, MD, oncologist at the Cleveland Clinic in Ohio.

Sketch of lymphoma cells in human lymph nodes

Elevated PFS With Acalabrutinib Combo Outperforms Standard Treatment in MCL

In previously untreated mantle cell lymphoma, the combination of acalabrutinib (Calquence) plus bendamustine and rituximab (Rituxan) substantially increased progression-free survival (PFS) vs placebo in the phase 3 ECHO trial (NCT02972840).

“These positive PFS results from the ECHO phase 3 trial could provide a new standard of care for patients with mantle cell lymphoma. Incorporating [acalabrutinib] into the first-line mantle cell lymphoma setting would give many more patients the opportunity to benefit from the robust efficacy and strong safety profile we’ve seen with this medicine,” Michael Wang, MD said in a press release. Wang is the Puddin Clarke Endowed Professor, director of Mantle Cell Lymphoma Program of Excellence, codirector of clinical trials at the University of Texas MD Anderson Cancer Center, and principal investigator of the trial.

Sketch of human GI tract

Pembrolizumab/Trastuzumab/Chemo Improves Overall Survival in HER2+ Gastric Cancer

Pembrolizumab (Keytruda) plus trastuzumab (Herceptin) and chemotherapy showed significant improvement in overall survival (OS) in patients with HER2-positive locally advanced unresectable or metastatic gastric or gastroesophageal junction. In the phase 3 KEYNOTE-811 trial (NCT03615326), the combination was compared with placebo and at the final analysis in the intention-to-treat population patients whose tumors expressed PD-L1 (combined positive score 1 or greater) had the most benefit.

“Patients diagnosed with advanced gastric cancer often face a poor prognosis, underscoring the need for treatment options that have the potential to extend patients’ lives,” said Marjorie Green, MD, senior vice president and head of oncology, global clinical development, Merck Research Laboratories, in a press release. “These OS results from KEYNOTE-811 are encouraging and build on the positive PFS, overall response rate and duration of response data from this study.”

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

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