JNJ announced new data from the Phase 1b/2 OrigAMI-1 study, which showed Rybrevant (amivantamab-vmjw) combined with chemotherapy demonstrated promising rapid and durable antitumor activity in patients with RAS/BRAF wild-type metastatic CRC who have not previously received anti-EGFR therapy.
Rybrevant plus chemotherapy show 49 % ORR in metastatic colorectal cancer
In the study, patients receiving Rybrevant plus chemotherapy were either in their first (26 %) or second line (74 %) of treatment for mCRC and had not been treated with specific anti-EGFR therapies. Patients receiving FOLFOX were oxaliplatin-naïve and patients receiving FOLFIRI were irinotecan-naïve. Forty-three patients were treated with Rybrevant along with either FOLFOX (20 patients) or FOLFIRI (23 patients). The median follow-up period was 7.3 months for Rybrevant plus FOLFOX and Rybrevant plus FOLFIRI. Patients treated with Rybrevant plus chemotherapy achieved an ORR of 49 %, median DOR of 7.4 months and median PFS of 7.5 months. Disease control was observed in 88 percent of patients. The safety profile of Rybrevant plus FOLFOX/FOLFIRI was manageable and consistent with each of the individual components, without any additive toxicity.
Imfinzi plus Imjudo demonstrated unprecedented OS in advanced liver cancer in Phase 3 trial
Updated results from the HIMALAYA Phase 3 trial showed AstraZeneca’s Imfinzi (durvalumab) plus Imjudo (tremelimumab) demonstrated a sustained, clinically meaningful OS benefit at five years for patients with unresectable HCC who had not received prior systemic therapy and were not eligible for localised treatment. These results from HIMALAYA will be presented today at ESMO Congress 2024. At five years of follow-up, this latest exploratory analysis showed that a single priming dose of Imjudo added to Imfinzi, called the STRIDE regimen (Single Tremelimumab Regular Interval Durvalumab), reduced the risk of death by 24% compared to sorafenib. An estimated 19.6% of patients treated with the STRIDE regimen were alive at five years versus 9.4% of those treated with sorafenib. In a subgroup analysis of patients in the trial who achieved disease control, defined as complete or partial response or stable disease, 28.7% of those treated with the STRIDE regimen were alive at five years versus 12.7% of patients treated with sorafenib. In addition, an exploratory analysis of depth of response (DpR) showed that more patients treated with the STRIDE regimen experienced deep responses leading to longer survival compared to sorafenib. The safety profile of the STRIDE regimen was consistent with the known profiles of each medicine, and no new safety signals were observed with longer follow-up.
iTeos announces positive ORR in GALAXIES Lung-201 study of TIGIT belrestotug plus dostarlimab
iTeos Therapeutics announced follow-up interim data from GALAXIES Lung-201, the Phase 2 platform study sponsored by iTeos’ development partner GSK, assessing the belrestotug + dostarlimab doublet in previously untreated, unresectable, locally advanced or metastatic PD-L1 high NSCLC. Clinically meaningful improvement in the primary endpoint of ORR was observed consistently across each belrestotug + dostarlimab cohort (63.3% Dose A, 65.6% Dose B and 76.7% Dose C compared to 37.5% with dostarlimab alone). cORR, defined as complete or partial response confirmed by repeat imaging ≥4 weeks after response criteria first met, was roughly 60.0% for each dose compared to 28.1% cORR for dostarlimab alone. Of the patients with evaluable paired ctDNA samples (baseline and week 7), median ctDNA reduction was 65% for dostarlimab monotherapy compared to 55% for Dose A, 94% for Dose B, and 97% for Dose C. Belrestotug + dostarlimab led to an increase in immune-related adverse events compared to dostarlimab monotherapy, which were generally manageable.
PanTera secures €93 million in Series A round to accelerate global actinium-225 production
PanTera, the Belgian radioisotope producer, today announces that it has completed a €93 million oversubscribed Series A fundraise led by EQT Life Sciences, with additional equity and debt funding bringing the total amount raised to €134 million. In addition to EQT Life Sciences, the €93 million Series A was joined by Kurma Partners, Eurazeo, Korys, Paladin and PMV. Alongside this, IBA, the world leader in particle accelerator technology, and SFPIM, a Belgian sovereign fund, will convert into equity €7.2 million convertible loans, further strengthening PanTera’s balance sheet. The oversubscribed round is the largest Series A round to date in the life sciences sector in Belgium. In parallel, the Company will also receive an additional in-kind contribution from SCK CEN to expand its business opportunities. Lastly, a binding term sheet for €33.75 million in debt has also been secured with KBC and Belfius with the support of Gigarant, a guarantee instrument of the Flemish Government.
