The Targeted Pulse: New Trial Evaluating Iadademstat/Azacitidine in MDS and Positive Trends in HNSCC

And The Fast Track Designation Goes To… PYX-201 in HNSCC

PYX-201 wins fast track status for patients with recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who have progressed on platinum-based chemotherapy and an anti–PD-L1/PD-1 therapy. PYX-201 is a first-in-concept antibody-drug conjugate and works by targeting extra domain-B fibronectin, which is a non-cellular structural component highly expressed in several tumor types. Two trials (NCT05720117; NCT06795412) that will evaluate this agent in various tumor types and are currently enrolling patients.

“Receiving fast track designation for PYX-201 from the FDA marks a significant milestone for Pyxis Oncology, recognizing our potential to address the significant medical need in R/M HNSCC. This designation underscores the urgency of bringing differentiated treatment options to patients and will help accelerate the development of PYX-201 as we actively recruit patients for our trial,” said Lara S. Sullivan, MD, president and chief executive officer, in a press release. “We look forward to working with the FDA to advance this promising therapy as efficiently as possible.” For more information on the trials, access the full article here.

“Potential New SOC:” Camizestrant/CDK4/6 Inhibitors in HR+/HER2- Breast Cancer

Camizestrant, in combination with CDK4/6 inhibitors, palbociclib (Ibrance), ribociclib (Kisqali), or abemaciclib (Verzenio), significantly improved progression-free survival in hormone receptor-positive, HER2-negative advanced breast cancer and emergent ESR1 mutations. In the phase 3 SERENA-6 trial (NCT04964934), This combination was compared with the standard of care (SOC), which consists of an aromatase inhibitor plus a CDK4/6 inhibitor.

“Patients have an urgent need for new treatments that delay disease progression on first-line endocrine-based therapies,” said François-Clément Bidard, MD, PhD, head of the Translational Research Group and a professor of medicine in the Department of Medical Oncology at Institut Curie & UVSQ/Université Paris-Saclay in France, in a press release. “The results from SERENA-6 show that switching from an aromatase inhibitor to camizestrant in combination with any of the 3 CDK4/6 inhibitors after emergence of an ESR1 mutation delays progression of disease and extends the benefit of first-line treatment, representing an important step forward for patients, and a potential shift in clinical practice.” For more trial data, access the full article here.

New Trial Initiated, Evaluating Iadademstat/Azacitidine in MDS

A phase 1, investigator-initiated, dose-finding trial (NCT06502145) has commenced, treating its first patient with myelodysplastic syndrome (MDS) using iadademstat (ORY-1001) plus azacitidine. Investigators in the trial aim to evaluate the safety and tolerability of iadademstat, a selective LSD1 inhibitor, in combination with SOC azacitidine.

“MDS is a hematologic neoplasm with limited treatment options and poor prognosis. Our study is evaluating a novel combination regimen for the frontline management of patients with MDS using LSD1 inhibitor iadademstat, in combination with hypomethylating agents, given the encouraging results of this combination in acute myeloid leukemia. We are excited to start the study and offer this option to our patients with MDS in need of novel therapies,” Guru Subramanian Guru Murthy, MD, MS, at the Medical College of Wisconsin Cancer Center in Milwaukee, said in a press release. For trial enrollment information and more, access the full article here.

Unchanged SOC Meets Pembrolizumab’s Priority Review in HNSCC

The FDA granted priority review to pembrolizumab (Keytruda) for resectable, locally advanced HNSCC. The indication includes neoadjuvant pembrolizumab, followed by adjuvant therapy with SOC radiotherapy, with or without cisplatin, and subsequent pembrolizumab monotherapy as maintenance. The FDA decision is based on topline data from the first prespecified interim analysis of the phase 3 KEYNOTE-689 trial (NCT03765918).

“The SOC for patients with resectable locally advanced HNSCC has remained the same for over 2 decades, representing a significant unmet need for new treatment options,” said Marjorie Green, MD, senior vice president and head of Late-Stage Oncology, Global Clinical Development, Merck Research Laboratories, in a press release. “Based on the compelling results of the KEYNOTE-689 trial, we hope to reduce the risk of recurrence and disease progression in earlier stages of disease. We look forward to working with the FDA to potentially bring [pembrolizumab] to these patients as soon as possible.” For more information on the KEYNOTE-689 study, access the full article here.

Proposed Cuts to Medicaid Threaten Access to Cancer Care

The proposed cuts to Medicaid directly affect patients with low income, child patients, and both their providers. In the first installment, Gwen Nichols, MD, explained the repercussions of the National Institutes of Health (NIH) funding freeze caused by procedural disruptions following the change in administration. In this second installment, Nichols provides insight into the proposed Medicaid cuts and who will be most affected by these changes.

“Although NIH funding cuts present long-term challenges for research, Medicaid reductions have an immediate impact on patient care. Many people are unaware that 50% of children with cancer receive Medicaid support,” Nichols explained. “Even families with private insurance often rely on Medicaid because of the high costs associated with treatment…If Medicaid becomes harder to access, these families will struggle to obtain life-saving treatments.” Nichols is executive vice president and chief medical officer of the Leukemia & Lymphoma Society. For more information on this, access the full article.

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 last week’s Targeted Pulse.