The Targeted Pulse: Promising New Agents Are Explored in Cold Tumors and Ovarian Cancer, Patritumab Deruxtecan Receives A CRL for EGFR-mutated NSCLC, and More


REGN7075 shows promise in cold tumors, dilutable thiotepa is approved, and patritumab deruxtecan receives a complete response letter for EGFR-mutated NSCLC. We also cover observed predictors for polycythemia vera and fast tract designation for TUB-040 for the treatment of platinum-resistant ovarian cancer.

REGN7075 Shows Efficacy in Cold Tumors, Expanding Immunotherapy Landscape

A new type of immunotherapy known as REGN7075 was evaluated in an ongoing phase 1/2 study (NCT04626635) and showed favorable results for cold tumors. The trial mainly included patients with microsatellite stable (MSS) colorectal cancer, historically unresponsive to immunotherapy. These data suggest that REGN7075 may be effective for other types of cancer that are unresponsive to immunotherapy, and plans to evaluate the effects of REGN7075 in other cancer types have been made.

“The aim is to turn cold tumors hot,” Neil Segal, MD, PhD, medical oncologist at Memorial Sloan Kettering Cancer Center, said in an interview with Targeted OncologyTM. “Going forward, the aim is to involve more patients and to do further assessment. There are expansion cohorts that have opened which include patients with lung cancer, cutaneous squamous cell cancer, [and] head and neck cancer, and we are treating additional patients with MSS colorectal cancer in backfill cohorts and expansion cohorts.”

Sketch of breast cancer

FDA Clears Dilutable Thiotepa Formulation for Breast and Ovarian Cancer

Thiotepa (Tepylute, formerly SH-105), in a ready-to-dilute formulation received approval from the FDA for the treatment of breast and ovarian adenocarcinoma. The agent has not undergone updated development since its initial approval in the 1950s. However, in this new form, thiotepa can improve efficiency and reduce preparation risks for clinicians, while also enhancing satisfaction and safety for patients due to its easier mode of administration.

“This approval fulfills an unmet need by addressing the shortcomings and handling complexities of the current lyophilized powder formulation,” said Sharon Cunningham, chief executive officer and co-founder of Shorla Oncology, in a press release. “We have taken a vital oncology drug and made it easier for oncology clinics and hospitals to use, while also reducing medical personnel exposure to a hazardous drug.”

Sketch of lung cancer

Patritumab Deruxtecan for EGFR-Mutated NSCLC Receives a Complete Response Letter

Patritumab deruxtecan (HER3-DXd) received a complete response letter from the FDA regarding its biologics license application (BLA) for treating advanced EGFR-mutated non–small cell lung cancer (NSCLC). Although no safety or efficacy issues were identified with the use of patritumab deruxtecan, the letter cited issues with third-party manufacturing following an inspection of their facility.

The BLA for patritumab deruxtecan is supported by data from the HERTHENA-Lung01 trial (NCT04619004), which is evaluating the agent in a patient population who previously progressed despite treatment with an EGFR-targeted tyrosine kinase inhibitor and platinum-based chemotherapy. Trial data were presented at the 2023 World Conference on Lung Cancer and published in the Journal of Clinical Oncology, reporting promising results.

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Predictors for Polycythemia Vera Progression Are identified in REVEAL Study

Observations from the phase 4 real-world, multicenter REVEAL study (NCT02252159) showed that the time from diagnosis to enrollment, elevated white blood cell (WBC) count, and variant allele frequency (VAF), were significantly associated with an increased risk of disease progression among patients with polycythemia vera (PV). These findings were presented during the 2024 European Hematology Association (EHA) Congress.

“Five predictors of PV progression were identified: disease duration, thrombotic event [TE] history, WBC count of greater than 11 × 109/L, hematocrit [HCT] level of 0.45 L/L or lower, and VAF. However, HCT [level] of 0.45 L/L or lower may be confounded by disease duration and cytoreductive treatment covariates,” study investigators wrote in a poster of the data presented at EHA. “These results provide additional support for the use of disease duration and elevated WBC and VAF as risk factors for disease progression and identify history of TEs as a potential novel risk factor.”

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The FDA Grants Fast Track to TUB-040 for Platinum-Resistant Ovarian Cancer

TUB-040, a next-generation NaPi2b-targeting exatecan antibody-drug conjugate (ADC), received fast track designation from the FDA for the treatment of platinum-resistant ovarian cancer. TUB-040 is currently being evaluated in the phase 1/2a NAPISTAR 1-01 trial (NCT06303505), which includes patients with platinum-resistant ovarian cancer or relapsed/refractory NSCLC. The study’s estimated completion date is January 2027.

“Almost all patients with ovarian cancer who are not cured by initial therapy will develop resistance to platinum-based therapy over time. Once platinum-resistant, therapeutic options for these patients are poor with highly unsatisfactory outcomes. The FDA’s fast track designation of TUB-040 is an important step in the development of TUB-040 to provide these [patients] with urgently needed new therapeutic options,” said Günter Fingerle-Rowson, MD, PhD, chief medical officer of Tubulis, in a press release. “The FDA decision brings us one step closer to our goal of delivering the true value of ADCs to patients in need, and we are grateful for the agency’s support on this path to develop TUB-040 fast and efficiently.”

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