China’s NMPA approves Tyvyt in esophageal cancer

CLINICAL AND REGULATORY

China’s NMPA approves Tyvyt in esophageal cancer

Tyvyt is already approved by NMPA to treat non-squamous NSCLC and refractory classical Hodgkin lymphoma, and is under review by the agency to treat gastric or gastroesophageal junction adenocarcinoma and EGFR-mutated non-squamous NSCLC. Tyvyt has faced regulatory setbacks in US due to a reliance on China-only data and is not approved by FDA for any indication.

Imfinzi combo meets mark in neoadjuvant lung setting

PD-L1 inhibitor Imfinzi durvalumab from AstraZeneca plus neoadjuvant chemotherapy significantly improved pathological complete response rates compared with chemotherapy alone among patients with resectable NSCLC, meeting one primary endpoint in the Phase 3 AEGEAN trial. The study will continue to evaluate the Imfinzi combo on a second primary endpoint, event-free survival. PD-1 inhibitor Opdivo gained FDA approval in March in a neoadjuvant NSCLC setting, making it the first immunotherapy authorized for use in pre-surgery NSCLC patients.

Checkpoint on track to add advanced cutaneous squamous cell carcinoma indication

Checkpoint Therapeutics plans to continue discussions with FDA about adding locally advanced cutaneous squamous cell carcinoma as a second indication in its upcoming BLA submission, planned for this year, for PD-L1 mAb cosibelimab. After previously reporting positive data in metastatic CSCC, an interim analysis of a clinical trial in 31 patients with locally advanced SCC yielded an objective response rate of 54.8%, exceeding the “clinically meaningful” lower bound of the 95% two-sided confidence interval of 25%, the company said, adding that it had designed the interim analysis based on feedback from FDA.

Epcoritamab shows best-in-class potential for DLBCL

The latest Phase 2 data from epcoritamab in DLBCL shows it may have best-in-class potential versus fellow anti-CD20 bispecific glofitamab, plus the potential to challenge autologous CD19-targeted CAR Ts on efficacy and milder safety. Partners Genmab and AbbVie presented data at the EHA congress that showed CD20xCD3 bispecific epcoritamab had a higher ORR and CR rate in the EPCORE NHL-1 trial than glofitamab from the Genentech showed in Phase 2 data presented at ASCO meeting. Both studies enrolled relapsed or refractory DLBCL patients. Epcoritamab’s 69% ORR and 42% CR in patients naive to CAR T treatment also puts the bispecific’s efficacy near that of the marketed CD19-targeting CAR T therapies, but with a much lower rate of Grade 3+ cytokine release syndrome. In a separate study, epcoritamab showed a 90% CR rate in newly-diagnosed DLBCL patients when used in combination with standard-of-care R-CHOP chemo.

FDA reviewing Keytruda in the new lung cancer setting

Keytruda could soon add yet another indication to its label, as FDA is reviewing the PD-1 inhibitor as adjuvant therapy in patients with Stage IB-III NSCLC that has been resected. The pharma said its PDUFA date is Jan. 29, 2023, though it may provide more data that could extend the review. Keytruda significantly extended disease-free survival in patients in the Phase 3 KEYNOTE-091 trial, regardless of PD-L1 expression, in that population.

DEALS AND FINANCING

Lightspeed and S.R. One back Ancora in $60 million Series A

Lightspeed Venture Partners and S.R. One have co-led a $60 million series A round for Ancora Biotech, which houses three bispecific antibodies spun out from TeneoBio. Ancora will advance TNB-486, a bispecific T cell engager targeting CD19 and CD3 that is in Phase 1 testing for B cell cancers; TNB-738, an anti-CD38 enzyme inhibitor for metabolic disorders currently in a study in healthy volunteers; and an HBsAg x CD3 bispecific for HBV. Amgen paid $900 million up front for TeneoBio last year. AbbVie had previously bought another of the asset-focused biotech’s programs.

Lifeline Ventures-backed Tilt Biotherapeutics raises $10M

With $10.7 million in new financing round, TILT Biotherapeutics will advance Phase 1/2 studies in Europe and US testing lead program TILT-123 plus immune checkpoint inhibitors to treat a range of cancers including ovarian, head and neck, and lung. The financing was the round’s first close and was led by Lifeline Ventures with participation from Tesi. The company also appointed Chief Regulatory Officer Tuija Keinonen as board chair. TILT-123 is an oncovirus engineered to express IL-2 and TNFɑ.