Months af­ter se­cur­ing FDA ap­proval for Tecen­triq as a first line of de­fense — in com­bi­na­tion with chemother­a­py — in ex­ten­sive-stage small-cell lung can­cer pa­tients, Roche on Thurs­day said the im­munother­a­py helped cer­tain treat­ment-naive pa­tients with ad­vanced non-small cell lung can­cer (NSCLC) live longer ver­sus chemother­a­py, in a piv­otal study.

The 572-pa­tient tri­al, called IM­pow­er110, test­ed Tecen­triq monother­a­py against chemother­a­py (cis­platin or car­bo­platin and peme­trexed or gem­c­itabine) in pa­tients with ad­vanced non-squa­mous and squa­mous non-small cell lung can­cer in pa­tients with­out ALK or EGFR mu­ta­tions.

The study met the main goal in an in­ter­im analy­sis show­ing that Tecen­triq monother­a­py sur­passed the ef­fect of chemother­a­py alone. “Tecen­triq monother­a­py has shown a sig­nif­i­cant sur­vival ben­e­fit over chemother­a­py as an ini­tial treat­ment in peo­ple with squa­mous or non-squa­mous non-small cell lung can­cer with high PD-L1 ex­pres­sion,” Roche’s out­go­ing CMO San­dra Horn­ing, said in a state­ment.

The study will con­tin­ue to con­duct the fi­nal analy­sis for pa­tients with low­er lev­els of PD-L1 ex­pres­sion, the Swiss drug­mak­er added. Roche is set to sub­mit the dataset — de­tails of which will be dis­closed at a fu­ture med­ical con­fer­ence — to health reg­u­la­tors in the Unit­ed States and Eu­rope.

Roche has nine Phase III lung can­cer stud­ies un­der­way eval­u­at­ing Tecen­triq as a monother­a­py or in com­bi­na­tion with oth­er med­i­cines across a pletho­ra of lung can­cer types.

Tecen­triq has al­ready se­cured US ap­proval in a num­ber of lung can­cer in­di­ca­tions. In March, it scored the ex­ten­sive-stage small cell lung can­cer (ES-SCLC) ap­proval, and last De­cem­ber the FDA en­dorsed the drug in com­bi­na­tion with Avastin for pa­tients with non-squa­mous non-small cell lung can­cer. The drug — which is al­so ap­proved for blad­der and breast can­cer — raked in sales of about $788 mil­lion in the first half of this year.

Lung can­cer is the lead­ing cause of can­cer death glob­al­ly, ac­cord­ing to the WHO. The two main types of lung can­cer are non-small cell and small cell, and NSCLC ac­counts for about 85% of all cas­es. Over­all, the NSCLC mar­ket is poised to grow to $14.6 bil­lion by 2024, ac­cord­ing to Glob­al­Da­ta es­ti­mates.

The Swiss drug­mak­er is carv­ing it­self a big­ger piece of the lu­cra­tive im­muno-on­col­o­gy mar­ket, which is large­ly mo­nop­o­lized by Mer­ck’s $MRK key­stone check­point in­hibitor Keytru­da, and to a less­er ex­tent Bris­tol-My­ers Squibb $BMY Op­di­vo. As­traZeneca’s $AZN Imfinzi is al­so gain­ing ground, par­tic­u­lar­ly in lung can­cer.

The FDA has rejected Incyte’s extended-release formulation of ruxolitinib tablets, in a surprise setback for the company’s plans to build on its blockbuster Jakafi franchise.

The ruxolitinib XR tablets are designed to be taken once a day, whereas Jakafi is indicated for twice daily dosage (although some patients can take it once daily).

According to Incyte, the FDA acknowledged in its complete response letter that the study submitted in the NDA “met its objective of bioequivalence based on area under the curve (AUC) parameters but identified additional requirements for approval.”

Cyclerion Therapeutics may have the design of a Phase IIb study ready to go, but it’s scrambling for a way to fund it.

The company said in a press release that it’s “actively evaluating the best combination of capital, capabilities, and transactions available to it to advance the development of zagociguat,” its lead candidate for a rare, genetic mitochondrial disease known as MELAS.

In a separate SEC filing, Cyclerion once again flagged “substantial doubt about (its) ability to continue as a going concern.” As of the end of 2022, it had cash and cash equivalents of only $13.4 million.

The European Commission has once again delayed the release of its proposal for an overhaul of the continent’s pharmaceutical legislation.

The release, previously anticipated on March 29, will occur “slightly later” than expected due to the “very busy College agendas of the last few weeks,” a Commission spokesperson told Endpoints News via email.

While the agency hasn’t provided an updated timeline, the spokesperson said the agenda is “always indicative and adoption dates of Commission proposals may change any time, especially when these proposals concern reforms of complex legislations of major importance.”