ITM presented positive topline Phase 3 data with 177Lu-edotreotide

CLINICAL AND REGULATORY 

ITM presented positive topline Phase 3 data with 177Lu-edotreotide

The trial results demonstrated that n.c.a. 177Lu-edotreotide (also known as ITM-11 or 177Lu-edotreotide), a proprietary, synthetic, targeted radiotherapeutic agent, met the primary endpoint and significantly prolonged progression-free survival in patients when compared to everolimus, a standard of care cancer treatment. COMPETE is a prospective, randomized, controlled, open-label Phase 3 trial that enrolled 309 patients with inoperable, progressive, Grade 1 or Grade 2 somatostatin receptor-positive neuroendocrine tumors of gastroenteric or pancreatic origin (Ki-67 ≤20%) in Europe, the United States, Australia and South Africa. Median PFS was significantly longer with 177Lu-edotreotide v. everolimus (23.9 vs 14.1 months), interim median OS was numerically higher, but not conclusive for 177Lu-edotreotide v. everolimus (63.4 vs 58.7 months). A lower proportion of patients experienced treatment-emergent adverse events related to study medication with 177Lu-edotreotide v. everolimus (82.5% vs 97.0%).

FDA approved tislelizumab for esophageal squamous cell carcinoma

BeiGene announced that FDA has approved Tevimbra (tislelizumab-jsgr) in combination with platinum-containing chemotherapy, for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1). The additional indication is based on results from BeiGene’s RATIONALE-306, a randomized, placebo-controlled, double-blind, global Phase 3 study to evaluate the efficacy and safety of Tevimbra in combination with platinum-containing chemotherapy as a first-line treatment in adult patients (n=649) with unresectable, locally advanced recurrent or metastatic ESCC. The study met its primary endpoint and demonstrated a statistically significant improvement in OS for adult patients randomized to Tevimbra in combination with chemotherapy compared to placebo in combination with chemotherapy.

Exploratory analyses indicated that the improvement in the intent-to-treat (ITT) population was primarily attributed to the results observed in the subgroup of patients with PD-L1 ≥1. Analysis of OS in the PD-L1 positive (≥1) population (n=481) showed a median OS of 16.8 months for patients treated with TEVIMBRA plus chemotherapy compared to 9.6 months for patients treated with placebo plus chemotherapy (HR: 0.66, [95% CI: 0.53, 0.82]), resulting in a 34% reduction in the risk of death. The most frequent serious adverse reactions (≥2%) were pneumonia, dysphagia, diarrhea, fatigue, and esophageal stenosis. The most common (≥20%) adverse reactions were anemia, fatigue, decreased appetite, nausea, constipation, decreased weight, diarrhea, peripheral sensory neuropathy, vomiting, and stomatitis.

FDA rejected camrelizumab plus rivoceranib for liver cancer treatment

The FDA has issued a second complete response letter (CRL) for camrelizumab plus rivoceranib as a frontline treatment for patients with unresectable or metastatic hepatocellular carcinoma (HCC), according to a news release. According to Jin Yang-gon, According to Korean news sources, the CRL did not specify what deficiencies regulators found. Data in this indication came from a presentation of the final analysis of the phase 3 CARES-310 study, presented at ASCO 2024, evaluating treatment with camrelizumab/ rivoceranib vs sorafenib in patients with unresectable or metastatic HCC. Findings from the study reveal a median OS benefit with camrelizumab/rivoceranib vs SOC TKI inhibitor sorafenib at 23.8 months (95% CI, 20.6-27.2) vs 15.2 months (95% CI, 13.2-18.5), respectively (HR, 0.64; 95% CI, 0.52-0.79; P < .0001).5 Additionally, the median PFS was 5.6 months (95% CI, 5.5-7.4) with the combination therapy vs 3.7 months (95% CI, 3.1-3.7) with SOC (HR, 0.54; 95% CI, 0.44-0.67; P < .0001).

CytomX and Amgen are axing their bispecific candidate after assessing the clinical data

CytomX Therapeutics announces during its 2024 financial results and business update presentation that based on CX-904 clinical observations to-date as well as CytomX pipeline priorities, CytomX and Amgen have jointly decided to not further develop CX-904. The compound is EGFRxCD3 targeting probody T-cell engager. CytomX said already in January that its plans to complete a Phase 1a trial and move into phase 1b were pending. The uncertainty stemmed from capital constraints that prompted CytomX to lay off 40% of its staff and consider how to spend its remaining dollars.