Read on for news about Immunocore, Arcus, CG Oncology, Genmab, Merck and GSK:
Merus stock spikes on data in head and neck squamous cell carcinoma: The biotech’s shares $MRUS rose more than 20% on Friday morning after sharing a Phase 2 trial assessing petosemtamab with Merck’s Keytruda as a first-line treatment. Among 10 patients evaluable for efficacy, there was one complete response and five partial responses (two confirmed and three unconfirmed as of the data cutoff). Merus is expected to release more data about the combo on Tuesday. — Max Gelman
No new safety info from MorphoSys: The abstract made no mention of acute myeloid leukemia among treatment-emergent adverse events. Last month, STAT reported six cases of patient diseases progressing to AML in the trial’s active arm, compared to two in the placebo group. The efficacy data are the same as those reported in November; pelabresib met the primary endpoint, achieving a p-value of p<0.001 when comparing the active and placebo arms, and a key secondary endpoint, called TSS50, saw a p-value of 0.216. MorphoSys declined to comment, citing its impending acquisition by Novartis. — Max Gelman
Immunocore stock drops after Ph1 melanoma bispecific data come out: In 31 melanoma patients, 19 had disease control after receiving Immunocore’s PRAMExCD3 bispecific T cell engager, known as IMC-F106C. That included four partial responses. The study enrolled patients with no other clinical options who had already received checkpoint inhibitors and had metastatic disease or weren’t eligible for surgery. Median progression-free survival was 4.5 months for patients who were PRAME-positive, compared to 2.1 months for the five who were PRAME-negative. At six months, 94% of those who were PRAME-positive were alive compared to two of five of those who were PRAME-negative. Immunocore’s stock $IMCR was down about 11% on Friday morning.
Immunocore is currently running a Phase 3 trial of IMC-F106C with Bristol Myers Squibb’s Opdivo in metastatic cutaneous melanoma. The company said additional data from the study will be shared on Friday afternoon. — Lei Lei Wu
Arcus outlines colon cancer data: In the Phase 2 ARC-9 study, the company showed that etrumadenant and zimberelimab significantly increased progression-free survival and overall survival in patients with previously treated colon cancer when given as part of a six-drug cocktail. PFS improved by 73% and OS by 63% over comparator arms of standard therapy. Etrumadenant is an adenosine receptor antagonist and zimberelimab is an anti-PD-1 antibody. Leerink analyst Daina Graybosch noted that “while it is more of a wild-card, we believe it is unlikely ARC-9 draws much investor enthusiasm to adenosine pathway targeting.” — Max Gelman
CG Oncology details bladder cancer combo that includes Merck’s Keytruda: The oncolytic virus-Keytruda combo resulted in a 57% complete response rate at 12 months in a Phase 2 study of patients with non-muscle invasive bladder cancer that did not respond to BCG. In bladder cancer, CG Oncology is aiming to compete with ImmunityBio, which recently received approval of Anktiva, as well as J&J. CG’s shares $CGON were up 7% on Friday morning. — Lei Lei Wu
Genmab reveals Ph2 lung cancer results: Acasunlimab, a bispecific targeting PD-L1 and 4-1BB, was tested with and without Keytruda in metastatic non-small cell lung cancer in three different regimens. As of a Jan. 9 cutoff, the unconfirmed overall response rate in the monotherapy regimen was 31%. In patients given the combo every three weeks, the ORR was 25%. And in those who were administered the combo every six weeks, the ORR was 30%. Confirmed ORRs, respectively, were 13%, 21% and 22%. — Max Gelman
Merck’s TIGIT drug scores in Ph2 trial: In a cohort of a Phase 2 trial, vibostolimab combined with Keytruda reduced tumors in women with advanced mismatch repair-deficient endometrial cancer. In the KeyVibe-005 study, the overall response rate was 65%, while 13% of patients had a complete response and 53% had a partial response, with the abstract concluding that the drug combo “demonstrated durable antitumor activity and a manageable safety profile.” — Katherine Lewin
GSK funds Ph3 study of Zejula in deadly brain cancer: The Ivy Brain Tumor Center at Barrow Neurological Institute ran a “trigger” study of Zejula, GSK’s PARP inhibitor, in patients with newly diagnosed glioblastoma. In the Phase 0/2 study, 46 patients received Zejula before brain cancer surgery. When their tumors were resected, samples were tested for drug activity and whether they were MGMT-unmethylated, a biomarker that predicts poor response to a standard brain cancer treatment called temozolomide.
For the 19 patients who enrolled in the Phase 2 part of the study, the median overall survival was 20.3 months — roughly double the historical survival times. Though the results came from a limited number of patients, GSK and the Ivy Brain Tumor Center are now collaborating on a Phase 3 study of Zejula versus temozolomide in MGMT-unmethylated glioblastoma, which is expected to begin in June and enroll 450 participants. — Lei Lei Wu