CLINICAL AND REGULATORY
BeiGene’s PD-1 inhibitor now approved for seven indications in China
China’s NMPA granted conditional approval to tislelizumab from BeiGene to treat adult patients with advanced unresectable or metastatic microsatellite instability-high or mismatch repair deficient solid tumors. Patients eligible for the humanized IgG4 anti-PD-1 mAb include those with advanced solid tumors whose disease has progressed after prior treatment, such as those with advanced colorectal cancer previously treated with fluoropyrimidine, oxaliplatin and irinotecan. In the US, FDA set a PDUFA date of July 12 for tislelizumab to treat unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma after prior systemic therapy.
FDA approves Novartis’ radiotherapy for prostate cancer
Another radioligand from Novartis became its latest to win FDA approval Wednesday when the agency authorized Pluvicto lutetium Lu 177 vipivotide tetraxetan (177Lu-PSMA-617) to treat PSMA-positive metastatic castration-resistant prostate cancer. The pharma gained Pluvicto via its $2.1 billion acquisition of Endocyte Inc., announced in October 2018. Novartis views its portfolio of radiotherapies as growth drivers; the pharma also markets Lutathera, a radiotherapy for gastroenteropancreatic neuroendocrine tumors.
Innovent and Lilly receive CRL for NSCLC candidate sintilimab
Innovent Biologics and Eli Lilly are assessing next steps for their jointly developed PD-1 inhibitor, sintilimab, following receipt of a complete response letter (CRL) from FDA. The pair sought approval of a BLA for sintilimab plus pemetrexed and platinum chemotherapy for the first-line treatment of people with non-squamous NSCLC but found near-unanimous opposition from FDA advisers dissatisfied with China-only trial data submitted in support of the application. The medicine is already approved for multiple indications in China, where it’s marketed as Tyvyt.
NuCana discontinues its Phase 3 trial evaluating Acelarin
NuCana’ stock fell following an independent data monitoring committee recommendation that the NuTide:121 Phase III study of acelarin plus cisplatin in biliary tract cancer be discontinued after the gemcitabine derivative failed to improve overall survival compared to the standard of care combination of gemcitabine plus cisplatin. The company also has derivatives of 5-FU, which will enter a Phase III study of colorectal cancer patients in 2H22; and cordycepin, for which it is expecting data readouts in solid tumors and lymphoma this year.
Checkpoint inhibitor Imfinzi misses in first-line cervical cancer
Imfinzi durvalumab from AstraZeneca missed the primary PFS endpoint in the Phase 3 CALLA to treat locally advanced cervical cancer, an indication where market-leading PD-1 inhibitors Keytruda pembrolizumab and Opdivo nivolumab have not been approved. Imfinzi plus chemoradiotherapy failed to significantly increase PFS over chemoradiotherapy alone in the first-line setting. Keytruda is approved to treat PD-L1-expressing recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
Roche undeterred by TIGIT miss, with readout due in larger lung cancer indication
Roche is looking ahead to a readout in a larger lung cancer population after the failure of its anti-TIGIT mAb in a Phase 3 trial to treat extensive small-cell lung cancer in a first-line setting. The pharma had only modest expectations for tiragolumab in the SKYSCRAPER-02 study, which evaluated the TIGIT antibody in combination with anti-PD-L1 Tecentriq atezolizumab and chemotherapy against those two therapies alone. Roche said tiragolumab missed the co-primary endpoint of progression-free survival. An interim analysis of overall survival did not show statistical significance, and the therapy is unlikely to meet the endpoint. The company does not expect SKYSCRAPER-02’s results to read through to other studies of tiragolumab, including the Phase III SKYSCRAPER-01 trial in first-line non-small cell lung cancer. Data from that study are due this half.
Immutep reports LAG-3 fusion protein shows low ORR in NSCLC combo
Immutep reported interim data from the second part of the Phase II TACTI-002 trial that showed LAG3 inhibitor eftilagimod alpha plus anti-PD1 mAb Keytruda pembrolizumab showed an overall response rate of 6% in 36 NSCLC patients who were refractory to PD-1 or PD-L1 therapy. The biotech said the 6-month overall survival was 73% with median OS not yet being reached, while the 6-month progression-free survival was 26%. Last November, Immutep reported Phase 2b data in breast cancer that raised questions about the fusion protein’s survival benefit.