Pilatus Bio Inc. is working to address a major under-addressed target of current checkpoint inhibitors: metabolic stress within solid tumors. “Traditional immunotherapies release immune ‘brakes,’ but they do not address the underlying metabolic stress in tumors,” Pilatus CEO and cofounder Raven Lin said. “That’s why more than 60% of solid tumor patients do not respond to treatment.”

Much-awaited detailed data from Exelixis Inc.’s phase III Stellar-303 study of zanzalintinib, presented at the European Society for Medical Oncology meeting, showed the third-generation, oral tyrosine kinase inhibitor in combination with Tecentriq (atezolizumab, Roche AG) reduced the risk of death by 20% vs. Stivarga (regorafenib, Bayer AG) in patients with previously treated non-microsatellite instability (MSI)-high metastatic colorectal cancer and are expected to pave the way for an NDA filing later this year.

The U.S. FDA has approved the priority sNDA for a new first-line maintenance therapy in extensive-stage small-cell lung cancer from Jazz Pharmaceuticals plc. Zepzelca (lurbinectedin) can now be combined with Tecentriq (atezolizumab, Roche AG) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Roche) as a maintenance therapy for adults who haven’t progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide.

As developers in the oft-troubled TIGIT class forge onward, Roche Holding AG’s Genentech unit provided an unfavorable update July 5 on the phase II/III Skyscraper-06 study testing anti-TIGIT candidate tiragolumab plus Tecentriq (atezolizumab) and chemotherapy vs. Keytruda (pembrolizumab, Merck & Co. Inc.) and chemo as first-line treatment for non-squamous non-small-cell lung cancer (NSCLC).

In the wake of ongoing criticism over the U.S. FDA’s 2021 accelerated approval of Biogen Inc.’s Alzheimer’s drug, Aduhelm, the percentage of novel drugs receiving accelerated approval last year was the lowest it’s been since 2018.

It’s been a long road, but Astrazeneca plc’s anti-CTLA4 antibody, tremelimumab, finally earned its first U.S. FDA nod, cleared for use in combination with anti-PD-L1 drug Imfinzi (durvalumab) to treat patients with unresectable hepatocellular carcinoma (HCC). The commercial impact of the dual checkpoint therapy, however, remains to be seen, as it goes up against Roche Holding AG’s combination of Avastin (bevacizumab) and Tecentriq (atezolizumab), which gained standard-of-care status in first-line HCC in 2021.

The U.S. FDA’s accelerated approval path is front burner these days, what with Congress looking to modernize the path through provisions added to the must-pass user fee legislation, the controversy still boiling over the FDA’s accelerated approval last year of Biogen Inc.’s Alzheimer’s drug, Aduhelm (aducanumab), and a number of recent withdrawals of drugs granted accelerated approval years ago.

If the FDA follows the advice of its Oncologic Drugs Advisory Committee (ODAC), both Keytruda and Tecentriq will remain on the U.S. market, for the time being, with accelerated approval as first-line treatments for certain patients with advanced or metastatic urothelial carcinoma. The committee voted 5-3 April 28 to recommend continuing accelerated approval for Merck & Co. Inc.’s Keytruda (pembrolizumab) and 10-1 for maintaining the accelerated approval of the Roche Group’s Tecentriq (atezolizumab) until the final data come in from a confirmatory trial that’s expected to be completed next year.

In a virtual meeting fraught with technical difficulties, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 7-2 April 27 that the accelerated approval for Tecentriq (atezolizumab) in combination with nab-paclitaxel as a treatment for unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) in adults with PD-L1+ tumors should continue as additional trials are conducted or completed.