Mirati Therapeutics Inc. has posted new data for its highly anticipated KRAS cancer fighter, adagrasib (MRTX-849), showing mixed results compared to its chief competition, Amgen Inc.’s Lumakras (sotorasib). Data from Mirati’s registration-enabling phase II cohort of the non-small-cell lung cancer (NSCLC) study, Krystal-1, showed an objective response rate (ORR) of 43%, a disease control rate (DCR) of 80%, a median duration of response (DOR) of 8.5 months and median progression-free survival (PFS) of 6.5 months. In April, Amgen released two-year data from the phase I/II study of its KRAS-G12C inhibitor for treating NSCLC that showed a lower ORR (40.7%), a higher DCR (83.7%), a longer median DOR (12.3 months) but slightly shorter median PFS of 6.3 months. With a PDUFA date of Dec. 14, 2022 adagrasib is one of seven potential blockbusters outlined in the Clarivate’s Drugs to Watch 2022. Cortellis data at the time of the report indicated a 35% probability of success in the U.S. The drug is anticipated to hit sales of as much as $1.27 billion in 2026. The San Diego-based company’s stock (NASDAQ:MRTX) however had slipped 33% at midday.
Iovance plunges on phase II data with melanoma treatment
Shares of Iovance Biotherapeutics Inc. (NASDAQ:IOVA) were trading midday at $7.14, down $7.98, or 52.81% after the firm disclosed results from registrational cohort 4 of the phase II C-144-01 study testing lifileucel (LN-144, autologous tumor infiltrating lymphocytes) in advanced melanoma. Enrolled were patients whose disease had worsened despite anti-PD-1/L1 therapy, and – if BRAF mutation-positive – also prior BRAF or BRAF/MEK inhibitors. The drug gained an objective response rate of 29% and a median duration of response of 10.4 months, with a median study follow-up of 23.5 months.
UK biotech Nanosyrinx begins platform play around synthetic biology tech
A U.K. biotech is aiming to build a new pipeline around a unique drug delivery system employing a naturally occurring protein called a “nanosyringe” to overcome the technical challenges of delivering therapeutic payloads to target cells. Nanosyrinx Ltd., of Warwick, based its technology on a naturally occurring bacterial toxin mechanism, which produces tiny virus-like particles. The synthetic biology approach has allowed the company to tweak the cellular machinery of bacteria to produce these nanosyringes loaded with drugs.
Sun sets on US HHS SUNSET Rule
A rule forcing the FDA and other agencies in the U.S. Department of Health and Human Services (HHS) to evaluate and clean out old regulations will never see the light of day. Carrying through on a proposal issued in October, HHS is formally withdrawing the so-called SUNSET Rule (Securing Updated and Necessary Statutory Evaluations Timely Rule), which was issued in the twilight of the Trump administration, according to a notice to be published in the May 27 Federal Register.
EMA tackles AMR with revised guidance
Facing the global threat of antimicrobial resistance (AMR), the EMA issued a final revised guideline on the evaluation of new antibiotics. In accordance with an agreement with the U.S. FDA and Japan’s Pharmaceuticals and Medical Devices Agency, the EMA’s guideline aligns as much as possible with the data requirements of those regulators so drug developers can design clinical trials that meet the evidence needs of all three agencies, the EMA said.
US FDA advises on prostate cancer drugs, Canadian imports
Among the latest guidances pouring out from the U.S. FDA are ones addressing the development programs for hormone analogues intended to treat advanced prostate cancer and prescription drug importation from Canada.
BioWorld’s offices will be closed in observance of Memorial Day in the U.S. No issue will be published Monday, May 30.
Also in the news
4D, Aadi, AB, Abbvie, Academab, Accord Healthcare, Adagene, Adaptimmune, Addex, Adicet, Advaxis, Affimed, Almirall, Altesa, Amgen, Amneal, Appili, Astrazeneca, Aulos, Aura, Axcella, Biomea Fusion, BMS, Bridgebio, Candel, Cantargia, Caris Life Sciences, Checkmate, Dizal, Eisai, Elevar, Elevation Oncology, Elicio, Exelixis, Galera, Gracell, Harpoon, Hookipa, I-Mab, Immuneering, Immunogen, Immutep, Inovio, Inspirna, Instil, Ionctura, Iovance, Ipsen, Karyopharm, Kashiv, Kintara, Leap, Lytix, Menarini, Mereo, Mirati, Modra, Mydecine, Neurona, Nouscom, Novalgen, Noxxon, Nurosene, Oncoinvent, Oncternal, Onquality, Oxford, PDS, Pionyr Immunotherapeutics, Protagonist, Revive, Roche, Scisparc, Seagen, Sotio, Springworks, Takeda, Tempest, Todos Medical, Total Brain, Verisim Life, Xencor, Y-mabs, Zymeworks