Axatilimab-csfr

Incyte has pointed to a spread of phase 1 data for its KRAS G12D inhibitor as proof that the company has a worthy rival to Revolution Medicines in this newly hot cancer space. Across four oral presentations at the European Society for Medical Oncology congress in Madrid, Incyte updated attendees on its cancer pipeline, including early-stage data on its KRAS G12D inhibitor, dubbed INCB161734, in patients with pancreatic ductal adenocarcinoma (PDAC). Among 28 patients who received INCB161734 in combination with the chemotherapy regimen modified FOLFIRINOX, the treatment achieved a confirmed objective response rate (ORR) of 81% and a disease control rate (DCR) of 100%, according to data from a July cutoff. In addition, the six-month progression-free survival (PFS) rate for these patients was 90%. The most common treatment-related adverse events (TRAEs) included diarrhea (which affected 67.9% of patients), nausea (64.3%), vomiting (57.1%) and decreased neutrophil count (57.1%). The trial also tested INCB161734 in combination with a different chemotherapy regimen, gemcitabine and nab-paclitaxel, in 26 patients. That combination achieved a confirmed ORR of 58%, a DCR of 96% and a six-month PFS rate of 80%. The TRAE profile was broadly similar. Incyte President and Global Head of R&D Pablo Cagnoni, M.D., told Fierce that the disparity between the ORRs in the two arms of the study was likely due to the different chemotherapies used. “If you look at the RevMed data, they also have better response for FOLFIRINOX,” said Cagnoni, referencing that company’s own KRAS G12D contender, zoldonrasib. RevMed made headlines in August when it secured FDA approval for its RAS inhibitor Rasonque as a pill for patients with metastatic pancreatic adenocarcinoma who had received prior treatment or were not candidates for multi-agent systemic therapy. While Rasonque targets multiple RAS mutations, zoldonrasib specifically targets RAS G12D, with the biopharma reporting an 82% ORR when the drug was combined with modified FOLFIRINOX in previously untreated patients with metastatic pancreatic cancer at this year's ESMO Gastrointestinal Cancers Congress. While zoldonrasib targets the “ON” state of RAS G12D, Incyte’s INCB161734 is an “ON/OFF” inhibitor. Despite these differences, Cagnoni sees the two drugs as broadly comparable. “Honestly, when I look at the data side by side, I think they're similar,” Cagnoni told Fierce during an interview on the conference sidelines. “I won't try to convince you we're better,” he added. “I am pretty certain we're no worse. I think we're neck and neck.” Incyte has already kicked off a global phase 3 trial of INCB161734 alongside chemotherapy in first-line metastatic PDAC, with topline data anticipated in 2028. The company also has plans for a separate phase 3 trial in the adjuvant setting. Meanwhile, RevMed has launched its own late-stage study of zoldonrasib in combination with chemotherapy for pancreatic cancer. “The way I see the space now, [Incyte and RevMed] are going to be in the front,” Cagnoni said. “Everybody else is far behind, and I haven't seen any data set from anyone that looks clearly better than us.” At ESMO, Incyte also served up data on INCB161734 in 49 patients with advanced or metastatic colorectal cancer. Among 22 heavily pre-treated patients who received INCB161734 alongside the cancer therapy Erbitux, the combination achieved an ORR of 36%, a DCR of 100% and a median PFS of 7.2 months. The company is gearing up to launch a late-stage study of INCB161734 and Erbitux in colorectal cancer next year. During ESMO, Incyte also revealed a collaboration with Genmab to test INCB161734 alongside the Danish biopharma's EGFR- and LGR5-targeting bispecific antibody petosemtamab and chemotherapy in the first-line setting. In addition, Incyte showcased its latest findings for INCA33890, a TGFβR2×PD-1 bispecific antibody, given alongside standard-of-care therapies in a phase 1 trial for metastatic microsatellite-stable colorectal cancer. Among 42 patients who received INCA33890 in combination with the chemotherapy regimen FOLFOX and Roche’s Avastin as a first-line treatment, Incyte reported an ORR of 71.4%, a DCR of 100% and a six-month PFS rate of 81.4%. With Incyte’s blockbuster JAK inhibitor Jakafi set to lose patent exclusivity in 2028, the KRAS readouts are “a key part of that story” of how the company future-proofs its business, according to Cagnoni. Part of the strategy is to “grow the non-Jakafi core business,” he said, name-checking the JAK inhibitor Opzelura, the upcoming FDA decision on povorcitinib for hidradenitis suppurativa, the blood cancer drug Monjuvi and the graft-versus-host disease treatment Niktimvo. “It's a series of products that, when you stack them, should deliver about three [to] three-and-a-half-billion dollars in sales by 2029, which is the first non-Jakafi year,” Cagnoni explained. “From there, what we have is a pipeline that we've been talking about that should deliver double-digit growth starting in 2031,” he added. This portfolio includes planned launches of INCB161734 in both pancreatic and colorectal cancer, alongside other assets such as a phase 3-stage CDK2 inhibitor for ovarian cancer.

Today, a brief rundown of news involving Johnson & Johnson and Gilead Sciences, as well as updates from the Federal Trade Commission, Syndax Pharmaceuticals and Pfizer that you may have missed.Johnson & Johnson shares fell 6% Tuesday despite delivering third-quarter results that met Wall Street expectations and hiking its 2026 financial guidance. Investors chief concern with J&J appears to be underwhelming performance from its medical device business, though the company also has a dearth of important upside catalysts, wrote RBC Capital Markets analyst Trung Huynh in a client note. Its unclear, Huynh noted, when one of J&Js most anticipated readouts a trial involving the next-generation blood thinner milvexian might come. Still, his team believes the share sell-off is excessive, emblematic of broader market volatility,and sets a negative tone for the sector as earnings season begins.Gilead Sciences is collaborating with Vir Biotechnology in a deal to develop T cell engagers for cancer. Vir is one of a few companies working on T cell engagers specially designed to evade immune system detection until reaching a tumor. Through Wednesdays deal, Vir and Gilead will direct three of these dual-masked therapies against unspecified solid tumor targets. Vir will receive $135 million in upfront and near-term payouts, and could gain up to $1.74 billion more if drugs in the agreement hit a variety of milestones. The alliance is the second recent pact for Vir following a deal with Astellas Pharma.The Federal Trade Commission and seven states have asked a New York judge to rule that Martin Shkreli has “flagrantly and repeatedly“ flouted a court order banning him from the pharmaceutical industry. In a motion filed Tuesday, the FTC and its co-plaintiffs alleged that, since his May 2022 release from prison, Shkreli has consistently violated the lifetime ban by trading in more than 60 industry stocks and “broadcasting his opinions“ about many pharmaceutical companies on various social media channels. They've called for Shkreli to be held in civil contempt and to divest ownership of any drug stocks. “Very surprising from [President Donald] Trump's FTC,“ Shkreli commented in a response on X. Shkreli drew broad criticism a decade ago, when his then-company bought a medicine called Daraprim and dramatically increased its price. He was later convicted of securities fraud and sentenced to seven years in prison.A drug Syndax Pharmaceuticals sells for graft-versus-host disease failed a mid-stage trial in idiopathic pulmonary fibrosis. Syndax said the therapy, known scientifically as axatilimab and sold as Niktimvo, didn't meaningfully improve a measure of breathing capacity when compared to a placebo. It'll stop developing Niktimvo in that indication, though the company stressed that the findings don't affect other ongoing studies. The study was a “high-risk, high-reward“ bet in a “historically difficult disease,“ wrote TD Cowen analyst Phil Nadeau. Nadeau also noted that partner Incyte hadn't opted into co-developing Niktimvo in IPF, one of multiple reasons his team's valuation of Syndax didn't change following the study setback.Pfizer will work with biotech startup Enodia Therapeutics on drugs that target a particular kind of protein gateway. Under the collaboration, the companies will develop small molecules that block Sec61, an opening newly made proteins pass through before theyre shepherded to their final destination. Enodia claims this approach enables it to target disease-causing proteins before they might cause harm. The startup could receive more than $500 million from Pfizer in the deal, though it didnt specify how much of that cash is guaranteed. '