AACR 2025 Tracker: Roche, Agenus and Artios Current New Information
The American Affiliation for Most cancers Analysis’s annual convention is in full swing, with Boehringer Ingelheim, Merck, GSK, Roche and extra presenting new information for oncology cornerstones and investigational candidates.
In the meantime, on Sunday, AACR CEO Margaret Foti closed the occasion’s opening ceremony with a uncommon condemnation of the Trump administration’s science and well being coverage strikes since January, STAT Information reported.
Keep tuned to BioSpace as we hold you up to date on the entire greatest information and information because the convention continues this week.
Up to date: April 29, 3:00 p.m. CST/4:00 p.m. EST
Artios’ Oral ATR Blocker Elicits Response in Half of Sufferers With Metastatic Stable Tumors
Within the Part I/IIa STELLA research, greater than a 3rd of sufferers handled with Artios Pharma’s investigational ATR inhibitor ART0380 plus low-dose irinotecan, had a confirmed remedy response.
These information, offered throughout an oral session at AACR 2025, come from 38 sufferers with superior or metastatic strong tumors who had no different passable remedy choices accessible to them. These research members had been handled with 200-mg ART0380—its really useful Part II dose—and 60-mg/m2 irinotecan at specified intervals.
These sufferers had been additionally poor for the ataxia-telangiectasia mutated (ATM) protein, a key marker for replication stress that’s current in as much as 1 / 4 of excessive–unmet want strong tumors, in line with Artios.
Tuesday’s information confirmed the ART0380 routine resulted in a 37% confirmed total response charge (cORR) in these sufferers. Within the subgroup of sufferers unfavourable for the ATM marker, cORR was 50%, with a median response period of 5.7 months. In these whose tumors examined optimistic for ATM however who confirmed low ranges of the protein, cORR was 22%, whereas median period of response had not but been reached on the time of readout.
Artios famous that ART0380 may elicit remedy responses towards eight tumor varieties, together with pancreatic and colorectal most cancers.
Roche’s TIGIT Postmortem Bares Particulars of Excessive-Profile Lung Most cancers Flop
When Roche introduced that its anti-TIGIT remedy tiragolumab failed the SKYSCRAPER-01 trial in non-small cell lung most cancers in November 2024, it didn’t present a lot element, leaving the business guessing at how dangerous the miss was.
That modified on Monday, when the pharma unveiled its detailed evaluation of the research, displaying that tiragolumab mixed with the PD-1 blocker Tecentriq lowered the danger of illness development or loss of life by 28% versus Tecentriq alone. This impact fell in need of statistical significance, with a p-value of 0.02.
Median total survival within the tiragolumab group was 23.1 months, versus 16.9 months in controls. This translated to a 13% drop within the danger of loss of life from any trigger, an impact that additionally failed to achieve significance.
As for security, Roche reported a better prevalence of toxicities in tiragolumab-treated sufferers, together with immune-mediated unintended effects similar to rashes, hepatitis and hypothyroidism.
Regardless of the Part III miss, the pharma however emphasised tiragolumab’s “numerical enhancements” in progression-free and total survival, which it claimed “recommend potential antitumor exercise of mixture PD-L1/TIGIT focusing on in NSCLC.”
Agenus’ PD-1/CTLA-4 Combo Remedy Demonstrates ‘Robust’ Exercise in Stable Tumors
On Monday, Agenus unveiled information from the Part II NEOASIS trial, touting encouraging response charges for its investigational PD-1/CTLA-4 remedy BOT/BAL in early-stage strong tumors.
In an investor word on Tuesday, Willaim Blair analysts known as these information “promising,” noting that pathological response information within the mismatch repair-proficient/microsatellite secure (MSS) cohort is “spectacular.”
BOT/BAL is a mix remedy composed of two medication: the anti-CTLA-4 antibody botensilimab and the PD-1 blocker balstilimab. NEOASIS is testing this investigational combo within the neoadjuvant setting for sufferers with non-metastatic strong tumors.
Information offered at AACR confirmed that within the subgroup of sufferers with mismatch repair-deficient/microsatellite instability-high tumors—9 had colorectal most cancers and one had duodenal most cancers—BOT/BAL elicited a 90% pathological response charge and a 70% pathological full response charge (pCR).
In the meantime, in these with MSS illness, pathological response was 80% whereas pCR was 20%. This subgroup included six sufferers with triple-negative breast most cancers, two with ER-positive breast most cancers, one with merkel cell carcinoma and one other with sarcoma.
In July 2024, the FDA discouraged an accelerated approval pathway for BOT/BAL, noting that goal response charges on this context could not translate to survival outcomes. Accordingly, William Blair is at present awaiting phrase from Agenus relating to the candidate’s path ahead, together with a possible partnership to help its additional improvement.
Merck Pads Case for Perioperative Keytruda in Superior Head and Neck Most cancers
Merck bolstered its case for Keytruda in head and neck most cancers with information from a Part III trial displaying the blockbuster PD-1 inhibitor may elicit “vital survival advantages” within the perioperative setting.
Within the Part III KEYNOTE-689 research, Keytruda, as a part of a perioperative remedy routine additionally containing adjuvant customary of care (SOC) radiotherapy with or with out cisplatin, improved event-free survival (EFS) by 27% within the research’s intention-to-treat inhabitants, besting a perioperative radiotherapy routine alone.
The trial is the primary “in additional than 20 years for sufferers with resected domestically superior head and neck squamous cell carcinoma,” in line with Merck’s Sunday press launch.
Merck filed a supplemental Biologics License Utility with the FDA for Keytruda on this indication and is anticipating a call by June 23.
For extra particulars, please learn the article.
GSK’s Jemperli Eliminates Want for Surgical procedure in dMMR Domestically Superior Cancers
Part II outcomes offered Sunday confirmed that GSK’s PD-1 inhibitor Jemperli can set off full tumor clearance in sufferers with domestically superior, mismatch repair-deficient (dMMR) cancers, no matter tumor sort.
These information, revealed concurrently within the New England Journal of Drugs, recommend that Jemperli may get rid of the necessity for surgical procedure in these sufferers.
Sunday’s findings come from 103 sufferers with stage II-III resectable dMMR cancers: 49 with rectal most cancers and 54 with nonrectal strong tumors similar to gastroesophageal and genitourinary cancers. After remedy with Jemperli, all 49 sufferers with rectal most cancers confirmed a scientific full response and determined to forego surgical treatment. Of those, 37 sustained their response ranges by 12 months of follow-up.
In the meantime, 35 sufferers with different most cancers varieties reached scientific full response, of whom 33 selected non-surgical administration. Total, 84 sufferers throughout each cohorts achieved full response, 82 of whom determined to skip surgical procedure.
Boehringer Ingelheim Touts Over 70% NSCLC Response Fee for Zongertinib
Boehringer Ingelheim’s investigational HER2 tyrosine kinase blocker zongertinib elicited a 71% goal response charge in sure sufferers with non-small cell lung most cancers (NSCLC) within the Part III Beamion LUNG-1 trial, in line with a Monday readout.
The research centered on sufferers with superior illness harboring HER2 mutations. Outcomes confirmed that 7% of sufferers achieved full remedy response, indicating no indicators of illness. Partial response was 64%, whereas illness management charge was 96%. Median progression-free survival was 12.4 months.
Of word, zongertinib additionally demonstrated intracranial exercise in 27 previously-treated sufferers with mind metastasis. On this subgroup, the candidate hit a response charge of 41% and a illness management charge of 81%.
Zongertinib was additionally secure total in Beamion LUNG-1, with no drug-related cases of interstitial lung illness, cardiotoxicity or deaths. Antagonistic occasions grade 3 or larger had been rare, and the most typical facet impact was diarrhea.
Boehringer Ingelheim filed its drug software for zongertinib in February, successful the FDA’s Precedence Evaluate designation. A call is predicted within the third quarter.
