Akeso wins NMPA approval for dual immune checkpoint inhibitor

CLINICAL AND REGULATORY

Akeso wins NMPA approval for dual immune checkpoint inhibitor

Kaitanni is now world’s first immune checkpoint inhibitor-based bispecific antibody to be commercialized. With a new conditional approval, it has also gained a head start over home-grown PD-1/L1 antibody rivals in the cervical cancer space. The approval was based on a 111-patient, single-arm Phase 2 pivotal trial conducted in China, which showed ORR of 33%, with a CR rate of 12% in 100 evaluable patients regardless of PD-L1 expression. ORR was 43.8% in the 64 PD-L1-positive (CPS≥1) patients in the study.

CHMP backing puts J&J’s CD3xBCMA bispecific on cusp of approval

A recommendation by EMA’s CHMP for the conditional approval of Tecvayli teclistamab, J&J’s CD3 x BCMA bispecific antibody for MM, was among the positive opinions for new medicines in July. It’s the first T cell redirecting bispecific antibody to treat relapsed and refractory MM to receive backing by the agency. The therapy, which has PRIME designation from EMA and is under review for use as monotherapy to treat fourth-line relapsed and refractory multiple myeloma, has yet to receive FDA approval. The PDUFA date is undisclosed.

Combination of Opdivo plus Yervoy misses in renal cell carcinoma adjuvant setting

The combination of Yervoy ipilimumab and Opdivo nivolumab missed the primary endpoint in Part A of the Phase 3 CheckMate-914 study evaluating the compounds as adjuvant therapy for renal cell carcinoma. The combination part of the study enrolled patients with localized renal cell carcinoma who have undergone full or partial removal of the kidney and are at moderate or high risk of relapse. The combination did not lead to a disease-free survival benefit in the adjuvant setting, even though it has shown survival benefits in other stages of RCC.

Delay for BeiGene’s tislelizumab BLA due to site inspection issues

FDA’s decision on an NDA for tislelizumab from BeiGene in esophageal cancer will be a signal to Chinese PD-1 developers of whether the door is still open to submissions based on non-US data for China prevalent indications, but they’ll have to wait longer than expected. After missing the July 12 PDUFA date, BeiGene announced that FDA deferred action on the BLA because it has been unable to conduct required inspections in China due to COVID-19 related travel restrictions. Tislelizumab is under review for second-line unresectable or metastatic esophageal squamous cell carcinoma.

Keytruda plus chemoradiotherapy misses in head and neck cancer

The combination of Keytruda and concurrent chemoradiation therapy to treat unresected locally advanced head and neck squamous cell carcinoma missed the primary endpoint in a Phase 3 trial, serving as a reminder that label expansions could become more difficult to obtain as the PD-1 inhibitor’s list of indications grows. Merck & Co. reported that Keytruda plus chemoradiotherapy followed by a year of Keytruda maintenance therapy led to improvements in event-free survival that were not statistically significant over placebo plus chemoradiotherapy followed by cisplatin.

MacroGenics closes head and neck cancer study combining enoblituzumab with checkpoint

MacroGenics said a higher-than-expected incidence of fatal hemorrhagic events in the CP-MGA271-06 study of enoblituzumab plus checkpoint inhibition in recurrent or metastatic squamous cell carcinoma of the head and neck was what led it to close the Phase II trial and halt treatment of the 62 patients already enrolled. Enoblituzumab is an Fc-optimized B7-H3-directed mAb that the company was investigating in combination with retifanlimab, an anti-PD-1 mAb or tebotelimab, a PD-1 × LAG-3 bispecific DART molecule. MacroGenics shares were off $0.25 to $3.25 in after-hours trading.

DEALS AND FINANCING

Takeda returns rights to oncolytic virus from Turnstone

Takeda has returned rights it had held under a 2019 deal in which it paid $120 million upfront. Takeda said it is giving away RIVAL-01 from its pipeline for strategic reasons. The program is in a Phase 1/2 trial to treat solid tumors, as monotherapy and in combination with Keytruda. The pharma’s broader partnership with Turnstone Biologics is ongoing. The biotech will once again have full rights to the oncolytic virus, which encodes immunostimulatory factors FLT3LG, IL-12 and an antibody against CTLA-4. The deal with Takeda included another $900 million in milestones.