MK-1084

“I think it is a little bit of a nice bubble to be in at the moment, given all that\'s going on in the world,” Takeda\'s Teresa Bitetti said.\n The first half of this year has been riddled with market volatility and geopolitical tension. But 2025’s American Society of Clinical Oncology conference largely isn’t reflecting that turmoil.In fact, despite the chill in the air, the Chicago-based five-day meeting has felt quite the opposite. Though ASCO\'s CEO Clifford Hudis, M.D., kicked off the event with a warning about the devastating impact President Donald Trump\'s massive proposed budget cuts would have on the National Institutes of Health\'s National Cancer Institute, most attendees focused in on the potential that current pipeline programs could bring to Americans with cancer.“In a fairly tumultuous world, where we just see concerns on funding and concerns on following the science, and then you come into a venue like this—it is energizing when you see the cutting-edge science and how smart some of these advancements are,” Teresa Bitetti, president of Takeda’s global oncology business unit, told Fierce Biotech at the conference. “I think it is a little bit of a nice bubble to be in at the moment, given all that\'s going on in the world,” Bitetti added.Specific to Takeda, Bitetti said the newly shared phase 3 data for the pharma’s Protagonist Therapeutics-partnered asset designed to treat a rare chronic blood disorder was also fueling her excitement.The injectable hepcidin mimetic, called rusfertide, already met the hematology trial’s main endpoint, demonstrating a 76.9% clinical response when paired with standard of care compared to a 32.9% response for those receiving standard of care alone. That finding, which was announced in March, is now supplemented by additional findings, including details on key secondary endpoints, all of which hit their target. The late-stage trial enrolled patients with polycythemia vera (PV), a disease that increases the risk of life-threatening cardiovascular and thrombotic events, and therefore boosts the chances of requiring the regular removal of blood via phlebotomy in order to manage hematocrit levels.However, only 27% of patients in the investigational treatment arm required phlebotomy over the duration of 32 weeks, compared to 78% of patients who received placebo plus the current standard of care.“If I had had this years ago when I was practicing, I think I would have just been in tears with joy,” P.K. Morrow, M.D., head of Takeda’s oncology therapeutic area unit, told Fierce. The company is now on track to submit an approval request to the FDA in the second half of Takeda\'s fiscal year, which ends March 31, 2026.“That\'s why I do love my job, it\'s not often in your career when you can bring forward a transformative medicine, and we\'re doing that,” Bitetti added. “That, to me, is super exciting and very fulfilling.”  The conference’s homebase, a sprawling convention center called McCormick Place, appears busy as ever. Fears that recent travel advisories cautioning international visitors from entering the U.S. would impact attendance seem not to have deterred global oncology leaders. A preliminary estimate from ASCO said international on-site registrations were on pace with last year, as of the second day of the conference.For Merck & Co.’s Marjorie Green, M.D., the conference remains a place to push forward with innovative cancer treatments.“Everyone is very happy with Keytruda, and we are too, but we know we can do better,” Merck’s senior vice president and head of oncology clinical development told Fierce. She cited Merck’s investigational KRAS G12C inhibitor, known as MK-1084, which the company is studying in a recently launched phase 3 for metastatic non-small cell lung cancer (NSCLC), plus a pivotal late-stage study slated to start next month in advanced colorectal cancer.In the NSCLC trial, the KRAS G12C inhibitor is being administered in combination with the company’s blockbuster PD-1 inhibitor Keytruda. The investigational duo will be compared against the standard of care in first-line metastatic nonsquamous NSCLC, which is Keytruda combined with pemetrexed and carboplatin.“So, we’re trying to get rid of chemotherapy,” Green explained. “Rewriting textbooks, that’s what we’re going to do.”And though, in the words of Fierce Pharma’s Angus Liu, this ASCO may not have “a lot of drama in the data” occurring, any chance to learn from other thought leaders and trials being presented is a golden one.“Even if a study is a negative study, you\'ve learned something important, and we build upon whatever that is,” Green said. “You\'ve answered an important question and are advancing science. We always want to advance progress for patients.”“The promise of ASCO is exciting,” she said.

MSD investigated the KRAS G12C inhibitor in patients with solid tumours, including advanced colorectal cancer and non-small cell lung cancer. Image credit: Shutterstock / Atmosphere1. MSD’s investigational KRAS G12C inhibitor has shown signs of anti-tumour activity when used both alone and in combination with other oncology drugs. Announcing the data at the American Society of Clinical Oncology (ASCO) meeting 2025, being held from 30 May to 3 June in Chicago, MSD said that MK-1084 was also safe and tolerable in patients with solid tumours, including advanced colorectal cancer (CRC) and non-small cell lung cancer (NSCLC), in the Phase I KANDLELIT-001 trial (NCT05067283). In patients with CRC, there was a 38% confirmed overall response rate (ORR) in the monotherapy arm. When used in combination with Erbitux (cetuximab), there was a 46% confirmed ORR, and when used with both Erbitux and mFOLFOX6(oxaliplatin and leucovorin plus 5-fluorouracil), the confirmed ORR was 38%. Investigators also reported 43% unconfirmed ORR with MK-1084 alone, 56% in combination with Erbitux and 66% in combination with Erbitux and mFOLFOX6. In patients with NSCLC, there was an ORR of 38% in the monotherapy arm, 77% when it was used in combination with Keytruda (pembrolizumab), and 53% when used with Keytruda and chemotherapy (carboplatin and pemetrexed). In all arms, MSD states that MK-1084 had a manageable safety profile. Treatment-related adverse events (AEs) occurred in 58% of patients in the MK-1084 monotherapy arm; 94% of patients in the MK-1084 and Keytruda arm;, 93% of patients in the MK-1084, Keytruda and chemotherapy arm; 95% of patients in the MK-1084 and Erbitux arm; and 97% of patients in the MK-1084 with Erbitux and mFOLFOX6 arm. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence MSD Research Laboratories SVP and oncology, global clinical development Dr Marjorie Green said: “We are encouraged by the promising early data from the KANDLELIT-001 study and look forward to further researching the potential for MK-1084, as monotherapy or in combinations, including with Keytruda in certain settings in patients with KRAS mutations, which are among the most prevalent mutations in cancer.” MSD is also investigating the KRAS G12C in several Phase III trials, including the Phase III KANDLELIT-012 study in patients with unresectable or metastatic CRC with KRAS G12C-mutated tumours and the Phase III KANDLELIT-004 study in patients with NSCLC with KRAS G12C-mutated tumours that express PD-L1 (NCT06345729). ASCO updates MSD also reported data from a Phase II/III study of zilovertamab vedotin as a combination therapy in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The study achieved a 56.3% ORR. Other major pharmaceutical companies have also revealed data around the ASCO 2025 conference. Pfizer announced data from its Phase III BREAKWATER study of Braftovi (encorafenib) in combination with Erbitux and mFOLFOX6. Merck KGaA also highlighted success in two studies, a Phase III trial of its CSF-1R inhibitor pimicotinib in tenosynovial giant cell tumour (TGCT) patients and a Phase I study of M9140, a CEACAM5-targeting antibody-drug conjugate (ADC), in patients with metastatic CRC . Pharmaceutical Technology Excellence Awards - Have you nominated? Nominations are now open for the prestigious Pharmaceutical Technology Excellence Awards - one of the industry's most recognised programmes celebrating innovation, leadership, and impact . This is your chance to showcase your achievements, highlight industry advancements , and gain global recognition . Don't miss the opportunity to be honoured among the best - submit your nomination today! Nominate Now