The Targeted Pulse: Discover the FDA’s Holiday Moves For Solid Tumors, Gastric, and GEJ Cancers

Subcutaneous Nivolumab Garners FDA Approval in Existing Solid Tumors

The subcutaneous formulation of nivolumab (Opdivo Qvantig) received FDA approval for all previously approved adult solid tumor indications as monotherapy, maintenance therapy, or in combination with chemotherapy or cabozantinib (Cabometyx). Data from the phase 3 CheckMate-67T study (NCT04810078) provided support for this approval. In the trial, subcutaneous nivolumab was compared with its intravenous formulation.

“Intravenous [nivolumab] has helped transform the treatment of several solid tumor types over the past decade, but there remains a need for additional administration options to address treatment burden on patients and improve efficiencies in healthcare systems,” said Gina Fusaro, PhD, vice president, global program lead, Bristol Myers Squibb, in a press release. “We believe this new option, given as a single injection administered in less than 5 minutes, could transform the treatment experience for both patients and physicians.” For more details on approval indication, read full article here.

Tislelizumab Gains FDA Approval in Advanced Gastric and GEJ Cancers

Tiselizumab (Tevimbra) in combination with fluoropyrimidine- and platinum-containing chemotherapy received FDA approval for newly diagnosed, locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma. Data from the global phase 3 RATIONALE-305 trial (NCT03777657) support the approval, demonstrating an improvement in overall survival and a manageable safety profile. In the trial, tiselizumab plus chemotherapy was compared with placebo plus chemotherapy. For detailed trial data, read the full article here.

Exploring Notable Achievements Throughout 2024 for Breast Cancer

In this article, Targeted Oncology^TM explores the top 10 advancements that occurred in 2024 for breast cancer. Highlights begin with an FDA approval for inavolisib (Itovebi, previously GDC-0077) with palbociclib (Ibrance) and fulvestrant for hormone receptor–positive (HR+), HER2-negative, PIK3CA-mutated breast cancer. Adjuvant ribociclib (Kisqali) in combination with an aromatase inhibitor also took home an FDA approval for HR+/ HER2-negative early breast cancer at high risk of recurrence, among other noteworthy approvals.

Other highlights include the encouraging results from the phase 3 OlympiA trial (NCT02032823), evaluating olaparib (Lynparza), and the I-SPY 2.2 trial (NCT01042379), evaluating neoadjuvant therapy based on tumor subtype. For the full list of breast cancer breakthroughs that occurred in 2024, read the full article here.

Specialist Provides Insight on Advanced Gastric Adenocarcinoma Case

In this article, David H. Ilson, MD, PhD, discussed a case of advanced gastric adenocarcinoma, explaining optimal treatment choices supported by data from the following phase 3 trials: CheckMate 649 (NCT02872116), KEYNOTE-859 (NCT03675737), and CheckMate 648 (NCT03143153). Ilson provides an expert perspective on the impact of various treatment combinations, as well as evaluating the safety profiles of the current treatment options available for this patient population.

“The better choice here is likely to be chemotherapy plus nivolumab because you do see this early drop-off in patients,” Ilson explained. “We have to be judicious in which patients we select for this regimen. Personally, I would treat patients with ipilimumab/nivolumab if the primary [tumor] were controlled and if they had low-volume metastatic disease, but it is an option and certainly a nonchemotherapy option if clinically appropriate.” Ilson is a gastrointestinal medical oncologist at Memorial Sloan Kettering Cancer Center in New York, New York. For the full discussion and case details, read the full article here.

Discussion on ctDNA as Ideal Biomarker in HER2+ Breast Cancer

In this article, Adrienne Waks, MD, discussed data from the DAPHNe trial (NCT03716180), which showed circulating tumor DNA (ctDNA) to be a promising biomarker for monitoring treatment response and minimal residual disease in HER2-positive breast cancer. In the trial, patients received neoadjuvant paclitaxel, trastuzumab (Herceptin), and pertuzumab (Perjeta), which was effective in clearing ctDNA. Waks is senior physician and the associate director of breast oncology clinical research at Dana-Farber Cancer Institute and an assistant professor of medicine at Harvard Medical School in Boston, Massachusetts.

“At baseline, with the tumor in place, the detectability rate was good, and that was one important finding for us. Over the 12 weeks of therapy, when we retested their ctDNA before surgery, we found that almost all of them had cleared their ctDNA—though not quite all, but almost all. Then, postoperatively, when we looked at their adjuvant therapy about a year later, the large majority—over 90% to 95%—had persistent clearance of circulating tumor DNA at those later time points,” said Waks. For the detailed discussion, read the full article here.

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

In case you missed it, here is the prior Targeted Pulse.