Checkmate Pharmaceuticals announced the presentation of new translational data from Checkmate's Phase 1b trial of vidutolimod in combination with pembrolizumab in patients with advanced anti-PD-1 refractory melanoma. Key highlights from these clinical data include: 93% of patients had progressive disease as their last response assessment on prior PD-1 blockade therapy, 42% had an elevated LDH, and the median sum of the target lesions longest diameter was 6.7 cm, indicating advanced disease; Response rates to vidutolimod in combination with pembrolizumab were similar across baseline patient characteristics including BRAF mutation, LDH level, number of prior systemic cancer treatments, best response to prior PD-1 blockade therapy, and prior ipilimumab; Responders and non-responders were not distinguished by baseline tumor characteristics including PD-L1 CPS, IFNg transcriptional signature, CD8+ T cells, or nonsynonymous mutations; All patients showed the expected rapid induction of anti-Qb antibodies to the virus-like particle, which facilitate the pharmacodynamic response to vidutolimod, and the antibody titers were not associated with clinical response; Clinical activity of vidutolimod in combination with pembrolizumab was associated with serum CXCL10 induction magnitude, induction of an inflammatory gene expression profile, and CD8+ T cells in injected and noninjected tumors.

Lyra Therapeutics presented data from its Phase 2 LANTERN study of LYR-210, the company's lead long-acting product candidate for chronic rhinosinusitis, at the Combined Otolaryngology Spring Meetings 2021. LYR-210 is an investigational product candidate designed to be administered in-office and to deliver a sustained release therapeutic for up to six months at difficult-to-access nasal inflammation sites, as a non-invasive alternative to surgery for patients who have failed medical management. Lyra reported positive topline data from the LANTERN study in December 2020. The COSM oral presentation, titled Long-acting implantable corticosteroid matrix for chronic rhinosinusitis: Results of LANTERN Phase 2 randomized controlled study, contains the full 24-week data set from the company's Phase 2 clinical trial of LYR-210. Previously unpublished data included: improvement from baseline in bilateral ethmoid Zinreich scores by magnetic resonance imaging; symptom improvement in both polyp and non-polyp patients; and the need for and use of rescue medication during the trial. In Polyp vs Non-Polyp patients, symptom improvement was observed in both polyp and non-polyp patients, with 100% of patients at the 7500microgram dose in each group achieving the minimal clinically important difference of 8.9 points for SNOT-22 total score by week 24, with a single administration of LYR-210. In the LANTERN study, subjects underwent paranasal sinus MRI at baseline as well as at the end of treatment. LYR-210 achieved improvement in bilateral ethmoid Zinreich scores at week 24 in a dose-dependent manner, providing evidence of disease modification, with the 7500microgram dose achieving significant improvement compared to control between the two timepoints. Only 1 patient in the 7500microgram group and 2 patients in the 2500microgram group required a rescue treatment compared to 7 patients in the control group over the 24-week treatment period. The first incidence of rescue treatment in the control group occurred at week 2, while the only patient to require rescue treatment in the 7500microgram group did not require rescue treatment until after week 18. As such, LYR-210 reduced the need for rescue treatment. The need for rescue treatment in the LANTERN study was determined by the treating physician. Separately, Lyra has shared an analysis of the LANTERN study focused on a composite of three of the cardinal symptoms of CRS. Lyra announced an analysis of a composite score of three cardinal symptoms of CRS, which includes nasal blockage, nasal discharge and facial pain, which are the most prevalent symptoms for surgically naive CRS patients both with and without nasal polyps. With a single administration, LYR-210 achieved statistically significant improvement in the 3CS composite score compared to control at week 24 and at earlier timepoints.

Eli Lilly announced for the first time data from the Phase 1/2 LIBRETTO-001 trial showing treatment with Retevmo demonstrated encouraging antitumor activity and safety across RET fusion-positive advanced solid tumors beyond lung and thyroid cancers, including multiple treatment-refractory gastrointestinal malignancies. In the Phase 1/2 LIBRETTO-001 trial, 32 adult patients with 12 unique RET fusion-positive advanced cancer types were enrolled by the efficacy cutoff date of September 19, 2020. Cancer types treated included pancreatic, colon, breast, salivary, sarcoma, carcinoid, rectal neuroendocrine, small intestine, xanthogranuloma, ovarian, pulmonary carcinosarcoma, and unknown primary cancers. Among the 32 patients, 62.5 percent had gastrointestinal tumors. Across all 32 patients, the confirmed objective response rate was 47 percent. Confirmed responses were observed in nine unique RET fusion-positive advanced cancer types. The median duration of response was not reached, with median follow-up of 13 months. Responses were ongoing in 73 percent of responding patients.

Greenwich LifeSciences presented a poster of the final 5 year GP2 Phase IIb clinical trial immune response data at the 2021 AACR Annual Meeting. Immune response is the primary mechanism of action for GP2 and is critical to developing dosing and booster treatment strategies that are designed to achieve and sustain peak immunity, as well as to prevent metastatic breast cancer recurrences. The company said that potent immune response data supports the previously reported clinical outcome of 0% metastatic breast cancer recurrences over 5 years of follow up, if a patient completes the Primary Immunization Series over the first 6 months of GP2 treatment. Statistically significant peak immunity was reached after 6 months of GP2 treatment as measured in both the Dimer Binding Assay and the DTH skin test. HER2 3+ population immune response was similar to the HER2 1-2+ population immune response, suggesting the potential to treat the HER2 1-2+ population with GP2 immunotherapy in combination with trastuzumab based products and other clinically active agents. Broad based immune response suggests that GP2 immunotherapy and Herceptin based products may also have the potential to treat other HER2 1-3+ expressing cancers.