ACCELERATE Trial

[Slide 1] Resected Chemotherapy alone Follow 6 cycles of mGemOx or GemCis gallbladder Randomization up cancer 20 ASCO Ga 25 Cancers Sy >pT2 or N+ ECOG <2 Age >18 3 cycles of chemotherapy mGemOx or CisGem f/b CRT ( radiation 45Gyin 25 Follow fractions in 5 weeks with concurrent R0/R1 oral capecitabine)* and further 2-3 up cycles of mGemOx or GemCis boost of 9 Gy in case of positive margin Gastrointestinal PRESENTED BY 1 PROF ATUL SHARMA MD DM ASCO AMERICA - SOCIETY OF Symposium #GI25 CLINICAL DISCOLOGY I property I and Permission KNOWLEDGE CONQUERS CANCER --- [Slide 2] Kaplan Meier Estimates for RFS (N=93) 1 Progression an Arm1=16 Arm2=22 .75 20 ASCO Gastrointestinal 25 Cancers Symposium .5 25 5 Log-Rankp=0 156 HR(95%CI): 1.59(0.83-3.03) aHR(95%CI): 1.09(0.54-2.17) 0 0 + + + $ & Months since Randomization Number at risk Adv-CT 48 37 32 27 19 10 Adv-CTRT 45 37 24 17 15 4 : : 95% CI 95% CI PROF ATUL SHARMA ARM = 1 ARM = 2 ASCO Gastrointestinal PROF ATUL SHARMA MD.DM #GI25 ASCO AMERICAN SOCIETY OF PRESENTED BY CUNICAL Cancers Symposium property author KNOWLEDGE CONQUERS CANCER ASCO Gastrointestinal Cancers Symposium --- [Slide 3] Kaplan Meier Estimates for os (N=93) 26 1 75 5 BULL 20 ASCO Gastrointestinal .5 25 Cancers Symposium 25 5 Log-Rankp=0.132 HR(95%CI): 1.60(0.86-2.95) aHR(95%CI): 1.16(0 61-2.22) O 0 2 28 36 $ 80 12 84 Months since Randomization Number at risk Adjv-CT 48 40 36 29 20 10 3 0 Adv-CTRT 45 40 29 17 15 4 1 0 95% CI 95% CI Adjuvant CT Adjuvant CTRT ASCO Gastrointestinal #GI25 BY PROF ATUL SHARMA MD, DM ASCO AMERICAN SOCIETY O CURICAL ONCOLOGY Cancers Symposium Presentation property author and ASCO Permission - contact permasons@asco.org KNOWLEDGE CONQUERS CANCER ASCO Gastrointestinal Cancers Symposium

[Slide 1] Phase III adjuvant chemotherapy trials Study name Sample Size Primary site Arms os benefit PRODIGE -12 196 EHCC . Gall Observation vs HR 0.68; (20% gall bladder) Bladder 95% CI 0 62-1 25, atin p=0-48 Japanese Bile Duct 225 EHCC only Observation VS HR 1 01; Cancer Adjuvant Gemcitabine 95% CI 0 70-1 45. Trial p=0 00 BILCAP 446 EHCC + Gall Observation vs HR 0 71 (18% Gall Bladder) Bladder Capecitabine 95% CI 0-55-0-92; p=0-010* JCOG 1202 440 EHCC + Gall Observation VS S1 HR 0-69. (15% Gall Bladder) Bladder 95% CI 0-51-0-94; p=0-008 Casine et.al. / Cancel Once 2016 550-47 Chata, et at. or / burg 2018, 10-202 Primium et.al. Lancel Onest 2018 083-73 NAMES K. Lancel 2025 in (1.401(10077) 5620 ASCO Gastrointestinal #G125 ASCO Cancers Symposium - --- [Slide 2] RFS estinal - Adjust CT Adjuvant CRT Not powered to detect significant difference 75 5 os Adjurt CT - Adjust ORT 25 5 Log Rankp+0 156 75 HR(95%O) 1.59(0 83 3 02) 0 xHR(95%O) 17) 0 3 * P 0 + + 9 Months since Randomization Number at risk Adv-CT OF 0 DD 0 0 6 a a V 0 is : 3 5 - CTRT - 25 Log-Rank DID 132 2-year OS HR (95%C) 159 (086-294) aHR (95%C) 1 18 (0 81-2.29) - 78% in chemotherapy arm (70% in PRODIGE) 0 0 " -65% in CRT arm (65% in S0809) : + 0 @ + Months since Randomization Number at risk ADVICT 0 43 - 3 is - , AB-CTRY n 40 3 0 . ASCO Gastrointestinal ASCO #G125 Cancers Symposium -

[Slide 1] Key takeaways This is the first prospective trial to address issue of adjuvant CRT in GBC There was no improvement in RFS by adding CRT to chemotherapy compared to chemotherapy alone in resected gallbladder cancer Since accrual could not be completed a larger trial is needed to address this important issue ASCO Gastrointestinal #G125 PRESENTED BY PROF ATUL SHARMA MD, DM ASCO AMEXICAN SOCIETY of CLINICAL ONCOLOCK Cancers Symposium Presentation . of the author and ASCO Permasion required to contact KNOWLEDGE CONOUERS CANCER --- [Slide 2] Kaplan Meier Estimates for RFS (N=93) Progression Arm1=16 Arm2=22 Log-Rank p=0.156 HR(95%CI): 1.59(0.83-3.03) aHR(95%CI): 1.09(0.54-2.17) 0 2 Months since Randomization Number at risk ASS-CT 48 37 32 27 19 10 3 0 ASV-CTRT 45 37 24 17 15 4 1 0 95% CI PROF ATUL SHARMA 95% CI ARM = 1 ARM = 2 ASCO Gastrointestinal PROF ATUL SHARMA MD,DM #GI25 PRESENTED BY Cancers Symposium ASCO AMERICAN SOCIETY OF CUNICAL ONCOLOGY Presentation . property and ASCO Permanent required h KNOWLEDGE CONQUERS CANCER --- [Slide 3] Treatment Arm 1(standard)- - Physicians choice of ChT alone (either 6 cycles of mGemOx- Gemcitabine 900 mg/m2 and oxaliplatin 80 mg/m2 IVI days 1 and 8 every 3 weeks or GemCis- Gemcitabine 1000 mg/m2 and cisplatin 25 mg/m2 1 and 8 every 3 weeks) Arm 2 (experimental)- - 3 cycles of ChT followed by CRT ( 45 Gy in 25 fractions over 5 weeks with concurrent capecitabine 825 mg/m2 twice a day on days of radiation) and further 2-3 cycles of ChT An additional boost of 9 Gy to limited area was considered in case of positive margin ASCO Gastrointestinal Cancers Symposium #GI25 PRESENTED BY PROF ATUL SHARMA MD.DM ASCO AMEXICAN SOCIETY OF CUNICAL CHICOLOGY / . property of the author and ABOO KNOWLEDGE CONOUERS CANCER --- [Slide 4] 12 Resected Chemotherapy alone Follow 6 cycles of mGemOx or GemCis gallbladder Randomization up cancer 2 or N+ ECOG <2 Age >18 3 cycles of chemotherapy mGemOx or CisGem f/b CRT ( radiation 45Gyin 25 fractions in 5 weeks with concurrent Follow RO/R1 oral capecitabine) * and further 2-3 up cycles of mGemOx or GemCis *further boost of 9 Gy in case of positive margin ASCO Gastrointestinal #GI25 PRESENTED BY PROF ATUL SHARMA MD.OM ASCO AMERICAN SOCIETTO CUNICAL ONCOLOCK Cancers Symposium Presentation a property of the author and ASCO Permission required to - contain KNOWLEDGE CONOUERS CANCER

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