SSGJ-707

Unlike its Big Pharma peers, which have launched aggressive clinical programs for their PD-(L)1xVEGF meds, Merck remains tight-lipped on its own plan.\n More than a year after licensing its PD-1xVEGF bispecific, Merck & Co. has finally unveiled the first clinical data from the antibody, which suggests the drug boasts similar safety and efficacy in non-small cell lung cancer compared with the field’s frontrunners.In what Merck describes as “early signs of promising anti-tumor activity,” the PD-1xVEGF bispecific, coded MK-2010, induced an unconfirmed overall response rate (ORR) of 55% among 11 previously untreated patients with PD-L1-positive non-small cell lung cancer. The results come from a Chinese phase 1/2 trial. The findings, shared in a poster at the American Association for Cancer Research (AACR) annual meeting, come from a 20 mg/kg once-every-three-weeks dose of MK-2010 in one of two randomized backfill cohorts of the study. Separately, in a 30 mg/kg group, the unconfirmed ORR was 44% among nine patients.This first glimpse of data teases Merck’s position in a high-stakes pursuit to develop the next immuno-oncology backbone to replace its megablockbuster Keytruda. However, unlike its Big Pharma peers, which have launched aggressive clinical programs for their PD-(L)1xVEGF candidates, Merck remains tight-lipped on its overall plans about 16 months into its global license agreement with LaNova Medicines, now part of Sino Biopharm. “While it is too early to disclose clinical development plans, we will leverage insights gleaned from our robust oncology development programs to inform where MK-2010, as a monotherapy and in various combination settings, may have the greatest benefit for patients,” a Merck spokesperson told Fierce Biotech.MK-2010’s ORR numbers look very similar to the 50% reported by Akeso and Summit Therapeutics’ first-in-class ivonescimab in the Harmoni-2 China phase 3 trial in a similar first-line NSCLC setting, or the 47% by BioNTech and Bristol Myers Squibb’s PD-L1xVEGF drug pumitamig in a small group of nonsquamous NSCLC patients, as well as the 62% and 55% from the 10 mg/kg and 20 mg/kg doses of Pfizer and 3SBio’s PF-08634404 (SSGJ-707) in early phase 2 results. But Merck’s results are simply too early and from too few patients to reach any conclusions, especially considering the varying proportions of patients with nonsquamous and squamous disease—as well as PD-L1-low and PD-L1-high cases—in all those studies.  More detailed resultsIn previously treated patients, the 20 mg/kg dose of MK-2010 recorded an 18% ORR among 22 patients in the backfill cohort, and the 30 mg/kg dose elicited a 22% ORR in 23 patients. Again, all the ORR numbers are unconfirmed.Altogether, 72 patients were included in the NSCLC backfill cohorts, compared with 40 in a dose escalation cohort that examined MK-2010—also known as LM-299—at various doses between 0.30 mg/kg to 40 mg/kg either once every two weeks or three weeks.At a data cutoff of Dec. 25, 2025, the median time from randomization was 7.9 months in the dose-escalation cohort and 3.3 months in the randomized backfill group. In terms of safety, two cases of dose-limiting toxicity were reported, including one grade 3 case of proteinuria (excessive protein in the urine) in the 30 mg/kg backfill arm and one grade 3 instance of hemoptysis (coughing up of blood) for a 3 mg/kg regimen in the dose escalation cohort, although the maximum tolerated dose has not been reached. Proteinuria is a common on-target side effect of VEGF inhibition. In Akeso’s Harmoni-2 trial, proteinuria was the most frequent treatment-related adverse event (TRAE) recorded for ivonescimab, dosed at 20 mg/kg every three weeks, landing at 32%, including 3% at grade 3 or above. For MK-2010’s 20 mg/kg backfill group, proteinuria was observed in 17% of patients, with no grade 3 or above cases. That’s compared with 24% of any grade, including some grade 3 events, for the 30 mg/kg cohort.Hypertension, another VEGF-related tolerability issue, was seen in 23% and 19% of patients in the two backfill cohorts, respectively, both including nearly but below 10% at grade 3. In contrast, ivonescimab’s TRAE hypertension rate was 16%, or 5% at grade 3 or above, in Harmoni-2.Bleeding, a major safety concern that prevents VEGF inhibitors from being used separately in squamous NSCLC, has been manageable with a PD-(L)1xVEGF bispecific construct. For MK-2010 specifically, bleeding events were recorded in 23% of patients, with no grade 3 or worse cases for the 20 mg/kg backfill group.Within the 30 mg/kg backfill cohort, 16% experienced bleeding. These include one grade 4 and one death (grade 5) of hemoptysis. In addition to hemoptysis, the higher-dose cohort also saw adverse events leading to death in three pneumonia cases and one case of cholestatic jaundice. The 20 mg/kg cohort also had one death due to respiratory failure. None of the five deaths were considered related to MK-2010 by investigator assessment, according to the poster. All told, the rate of grade 3 or worse treatment-emergent adverse events (TEAEs) came in at 23% for the 20 mg/kg backfill, 49% for the 30 mg/kg cohort and 53% for MK-2010 in the dose escalation cohort.Grade 3 or worse TRAEs were 17%, 27% and 40%, respectively, and led to one treatment discontinuation in the dose escalation group.By comparison, in Harmoni-2, ivonescimab’s grade 3 or above TRAE rate arrived at 22%. TRAEs led to permanent discontinuation in three (2%) patients who got the Akeso/Summit drug.MK-2010’s safety data include both treatment-naïve and previously treated patients, while ivonescimab’s results are exclusively from first-line patients.“We are encouraged by the early signals of clinical activity and a manageable safety profile of MK-2010 that was seen in these results,” the Merck spokesperson said. MK-2010 showed comparable efficacy between the two backfill cohorts, “with a more favorable safety and tolerability profile in the 20 mg/kg group,” the spokesperson added. “These data support further investigation of MK-2010 as monotherapy and in various combination settings,” the spokesperson said.Merck’s lack of any public phase 3 plans for MK-2010 comes in stark contrast with the multiple pivotal trials from Summit/Akeso, BMS/BioNTech and Pfizer/3SBio. As the class’s leader, Summit has already submitted ivonescimab for FDA approval in EGFR-mutated NSCLC based on mixed results from the phase 3 Harmoni trial, and it’s awaiting an interim progression-free survival readout from the squamous cohort of the phase 3 Harmoni-3 study in first-line NSCLC. Meanwhile, pivotal trials that BMS and BioNTech have launched for pumitamig include in first-line settings of NSCLC, extensive-stage SCLC, triple-negative breast cancer, kidney cancer, colorectal cancer, gastric cancer, liver cancer and head and neck cancer. After wrapping up its licensing agreement with 3SBio near the end of July 2025, Pfizer had launched three phase 3 trials for PF-08634404 by the end of last year and has plans to start another five studies by June this year. Merck’s lack of movement here also raises doubts about its commitment to the PD-1xVEGF space, especially as the New Jersey pharma pours major resources into its massive, so far 17-trial phase 3 program for the Kelun-Biotech-partnered TROP2 ADC, sac-TMT.“With their strong oncology development capabilities, we believe that Merck could quickly catch up to competitors in the class, if they so choose to do so,” Leerink Partners analysts wrote in a March 18 note to clients.

Pfizer has sponsored a series of posts encouraging people to visit its screening website. Actor, producer, and artist Lucy Liu has joined Pfizer’s mission to deliver a knockout blow against cancer, becoming the latest face of the Big Pharma’s campaign encouraging people to get screened.Liu, a star of movies including “Charlie’s Angels” and “Kill Bill,” shared a Pfizer-sponsored social media post about cancer screening with her 1.8 million Instagram followers. The video opens with text saying, “In the fight against cancer, every screen matters,” followed by “we're taking over this screen for cancer screenings.” Then Liu delivers the line “the most important screen is the one that has the potential to save your life.”Across the rest of the video, Liu discusses how cancer has affected her and her loved ones. Focusing on breast and prostate cancer, indications where Pfizer sells drugs such as Ibrance and Talzenna, Liu says she has seen “how early detection has the possibility to change the course of everything.” Some of Liu’s friends and family chose to get screened, caught their cancers early and are alive today. Other people were diagnosed too late to receive life-saving treatment. Early detection gives people the chance to act sooner with more options and information, Liu said. Liu ends the video with a line telling viewers to talk to their doctor and schedule a cancer screening using a Pfizer website. The Pfizer website, which is also referenced in the text post accompanying the video, asks visitors to enter information about their age, smoking history and cancer cases in their family. Users receive a list of recommended screenings and links to doctors based on their responses. Pfizer has sponsored a series of posts encouraging people to visit the website. In April, which is cancer prevention and early detection month, Liu and an anesthesiologist with 1.5 million Instagram followers, Myro Figura, M.D., have shared sponsored posts. Breast cancer advocate Katie Thurston posted a Pfizer-partnered video last month. Actor Hill Harper, physician, author and TV personality Jacqueline Walters, M.D., and businesswoman Tina Knowles published posts in February. Liu’s post followed the format established in the earlier updates, which start with the text and line about “the most important screen.”Oncology is a key therapeutic area for Pfizer, which expanded its presence in the space in 2023 with the $43 billion takeover of Seagen. The Big Pharma has continued to invest in oncology, naming the area as a driver of last year’s 4% rise in R&D spending and committing to a broad clinical program for its PD-1xVEGF bispecific antibody PF'4404.